Other products from "INOVA DIAGNOSTICS, INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 08430793040570 724121 The Celiac Disease IgA Calibrators include antibodies to tTG and DGP.1. Aptiva C The Celiac Disease IgA Calibrators include antibodies to tTG and DGP.1. Aptiva Celiac IgA Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies in stabilizers and preservatives. 2. Aptiva Celiac IgA Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies in stabilizers and preservatives.3. Aptiva Celiac IgA Calibrator 3: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies in stabilizers and preservatives. JIX Calibrator, Multi-Analyte Mixture 2 Aptiva® Celiac Disease IgA Calibrators
2 08426950845263 701342 1. QUANTA Flash RF IgM Negative Control: Two (2) barcode labeled tubes containin 1. QUANTA Flash RF IgM Negative Control: Two (2) barcode labeled tubes containing 0.5mL, ready to use reagent. Controls contain human antibodies to RF IgM in stabilizers and preservatives.2. QUANTA Flash RF IgM Positive Control: Two (2) barcode labeled tubes containing 0.5mL, ready to use reagent. Controls contain human antibodies to RF IgM in stabilizers and preservatives. JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 QUANTA Flash RF IgM Controls
3 08426950594994 701237 1. QUANTA Flash aCL IgM Low Control 3 x 1 mL barcoded tubes of a solution with a 1. QUANTA Flash aCL IgM Low Control 3 x 1 mL barcoded tubes of a solution with aCL IgM in saline solution containing fetal bovine serum stabilizers and preservative.2. QUANTA Flash aCL IgM High Control 3 x 1 mL barcoded tubes of a solution with aCL IgM in saline solution containing fetal bovine serum, stabilizers and preservative. JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 QUANTA Flash® aCL IgM Controls
4 08426950793175 701332 1. QUANTA Flash HMGCR Negative Control: Two (2) barcode labeled tubes containing 1. QUANTA Flash HMGCR Negative Control: Two (2) barcode labeled tubes containing 0.5mL, ready to use reagent. Controls contain human antibodies to HMGCR in stabilizers and preservatives.2. QUANTA Flash HMGCR Positive Control: Two (2) barcode labeled tubes containing 0.5mL, ready to use reagent. Controls contain human antibodies to HMGCR in stabilizers and preservatives. JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 QUANTA Flash® HMGCR Controls
5 08426950766988 701296 1. QUANTA Flash LKM-1 Calibrator 1: Two (2) barcode labeled tubes containing 0.3 1. QUANTA Flash LKM-1 Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to LKM-1 in stabilizers and preservatives.2. QUANTA Flash LKM-1 Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to LKM-1 in stabilizers and preservatives.3. QUANTA Flash LKM-1 Calibrator 3: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to LKM-1 in stabilizers and preservatives. JIT Calibrator, Secondary 2 QUANTA Flash® Lkm-1 Calibrators
6 08426950730095 701302 1. QUANTA Flash M2 (MIT3) Negative Control: Two (2) barcode labeled tubes contai 1. QUANTA Flash M2 (MIT3) Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to M2 (MIT3) in stabilizers and preservatives.2. QUANTA Flash M2 (MIT3) Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to M2 (MIT3) in stabilizers, and preservatives. JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 QUANTA Flash® M2 (MIT3) Controls
7 08426950729938 701301 1. QUANTA Flash M2 (MIT3) Calibrator 1: Two (2) barcode labeled tubes containing 1. QUANTA Flash M2 (MIT3) Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to M2 (MIT3) in stabilizers and preservatives.2. QUANTA Flash M2 (MIT3) Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to M2 (MIT3) in stabilizers and preservatives.3. QUANTA Flash M2 (MIT3) Calibrator 3: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to M2 (MIT3) in stabilizers and preservatives. JIT Calibrator, Secondary 2 QUANTA Flash® M2 (MIT3) Calibrators
8 08426950622208 701125 1. 1 QUANTA Flash CCP3 Reagent Cartridge2. 1 Resuspension Buffer 63. 1 Transfer pipet NHX Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) 2 QUANTA Flash® CCP3 Reagents
9 08426950602118 708300 "1 .20x ANCA (Formalin Fixed Human Neutrophil), slides - 12 wells2. 1x 15mL FITC "1 .20x ANCA (Formalin Fixed Human Neutrophil), slides - 12 wells2. 1x 15mL FITC IgG Conjugate with DAPI 3. 1x 0.5 mL cANCA Positive4. 1x 0.5 mL pANCA Positive 5. 1x 0.5mL IFA System Negative Control6. 2x25mL PBS II Concentrate (40x)8. 1x 7mL Mounting Medium9. 1x 20 Coverslips10. 1x Direction Insert" MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca) 2 NOVA Lite® ANCA (Formalin) Kit with DAPI
10 08426950601890 701100 1. 1 QUANTA Flash h-tTG IgA reagent cartridge2. 1 Resuspension buffer 3. 1 Transfer pipet MVM Autoantibodies, Endomysial(Tissue Transglutaminase) 2 QUANTA Flash® h-tTG IgA Reagents
11 08426950595670 704625.10 1. Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating 1. Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating the expected performance of the batch.3. Phosphatidylserine Coated Wells: 10 plates containing 12 breakapart 8 well strips coated with Phosphatidylserine antigen. Each plate is packaged in a re-sealable foil bag containing 2 desiccant pouches.4. PS Sample Diluent: 19 bottles containing 50mL of buffer for sample dilution. Coloured straw, ready to use.5. PBS Wash Concentrate (20x): 10 bottles containing 50mL of a 20-fold concentrated buffer for washing the wells. 6. Phosphatidylserine IgG ELISA Calibrators: 25 bottles (5 bottles each) containing 1.2mL of diluted human serum, with the following concentrations of anti-Phosphatidylserine autoantibody: 100, 33.3, 11.1, 3.7, 1.23 GPS U/mL. Ready to use.7. Phosphatidylserine IgG Positive Control: 5 bottles containing 1.2mL of diluted human serum. The expected value is given on the QC certificate.Ready to use.8. ELISA Negative Control: 5 bottles containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.9.HRP Phosphatidylserine IgG Conjugate: 10 bottles containing 10mL of purified peroxidase labelled antibody to human IgG. Coloured red, ready to use.10. TMB Chromogen: 10 bottles containing 10mL TMB substrate. Ready to use.11. HRP Stop Solution: 10 bottles containing 10mL of 0.344M Sulfuric acid. Ready to use. MID System, Test, Anticardiolipin Immunological 2 QUANTA Lite® Phosphatidylserine IgG ELISA Bulk Pack
12 08426950595151 701118 1. 1 QUANTA Flash RNP Reagent Cartridge2. 1 Resuspension buffer 3. 1 Transfer pipet LKO Anti-Rnp Antibody, Antigen And Control 2 QUANTA Flash® RNP Reagents
13 08426950594901 704630.10 1. Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating 1. Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating the expected performance of the batch.3. Phosphatidylserine Coated Wells: 10 plates containing 12 breakapart 8 well strips coated with Phosphatidylserine antigen. Each plate is packaged in a re-sealable foil bag containing 2 desiccant pouches.4. PS Sample Diluent: 19 bottles containing 50mL of buffer for sample dilution. Coloured straw, ready to use.5. PBS Wash Concentrate (20x): 10 bottles containing 50mL of a 20-fold concentrated buffer for washing the wells. 6. Phosphatidylserine IgM ELISA Calibrators: 25 bottles (5 bottles each) containing 1.2mL of diluted human serum, with the following concentrations of anti-Phosphatidylserine autoantibody: 100, 33.3, 11.1, 3.7, 1.23 GPS U/mL. Ready to use.7. Phosphatidylserine IgM Positive Control: 5 bottles containing 1.2mL of diluted human serum. The expected value is given on the QC certificate.Ready to use.8. ELISA Negative Control: 5 bottles containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.9. HRP Phosphatidylserine IgM Conjugate: 10 bottles containing 10mL of purified peroxidase labelled antibody to human IgM. Coloured blue, ready to use.10. TMB Chromogen: 10 bottles containing 10mL TMB substrate. Ready to use.11. HRP Stop Solution: 10 bottles containing 10mL of 0.344M Sulfuric acid. Ready to use. MID System, Test, Anticardiolipin Immunological 2 QUANTA Lite® Phosphatidylserine IgM ELISA Bulk Pack
14 08426950594765 701107 1. QUANTA Flash h-tTG IgG Negative Control: Two (2) barcode labeled tubes contai 1. QUANTA Flash h-tTG IgG Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to h-tTG in stabilizers and preservatives.2. QUANTA Flash h-tTG IgG Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to h-tTG in stabilizers, and preservatives. JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 QUANTA Flash® h-tTG IgG Controls
15 08426950593966 708415 1. 8 prepunched NOVA Gel titering ""T"" plates2. 2 0.4mL Sm/RNP antigen, lyophil 1. 8 prepunched NOVA Gel titering ""T"" plates2. 2 0.4mL Sm/RNP antigen, lyophilized3. 1 0.7mL Sm Control4. 1 0.7mL RNP Control LLL Extractable Antinuclear Antibody, Antigen And Control 2 NOVA Gel® Sm/RNP “T” Extractable Autoantibody Reagents
16 08426950593928 704610.10L 1. Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating 1. Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating the expected performance of the batch.3. Human Transglutaminase Coated Wells: 12 breakapart 8 well strips coated with recombinant tTG. Each plate is packaged in a re-sealable foil bag containing two desiccant pouches.4. HRP Sample Diluent: 2 bottles containing 50mL of buffer for sample dilution. Colored pink, 5. HRP Wash Concentrate: 1 bottle containing 25mL of a 40-fold concentrated buffer for washing the wells.6. R h-tTG IgG Calibrators: 5 bottles, each containing 1.2mL of diluted human serum, with the following concentrations of anti-tTG IgG autoantibody: 100, 33.3, 11.1, 3.7, 1.23 U/mL. 7. R h-tTG IgG Positive Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. 8. ELISA Negative Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. 9. HRP R h-tTG IgG Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgG. Colored blue. 10. TMB Chromogen: 1 bottle containing 10mL TMB chromogen. 11. Stop Solution: 1 bottle containing 10mL of 0.344M Sulfuric Acid. MVM Autoantibodies, Endomysial(Tissue Transglutaminase) 2 QUANTA LITE® R h-tTG IgG ELISA Bulk Pack (Lab Corp)
17 08426950593560 704605.10L 1. Instruction leaflet: Giving full assay details.2.QC Certificate: Indicating t 1. Instruction leaflet: Giving full assay details.2.QC Certificate: Indicating the expected performance of the batch.3. Human Transglutaminase Coated Wells: 12 breakapart 8 well strips coated with recombinant tTG. Each plate is packaged in a re-sealable foil bag containing two desiccant pouches.4. HRP Sample Diluent: 2 bottles containing 50mL of buffer for sample dilution. Colored pink, ready to use.5. HRP Wash Concentrate: 1 bottle containing 25mL of a 40-fold concentrated buffer for washing the wells.6. R h-tTG IgA Calibrators: 5 bottles, each containing 1.2mL of diluted human serum, with the following concentrations of anti-tTG IgA autoantibody: 100, 33.3, 11.1, 3.7, 1.23 U/mL. 7.R h-tTG IgA Positive Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. 8.ELISA Negative Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate..9. HRP R h-tTG IgA Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgA. Colored yellow. 10. TMB Chromogen: 1 bottle containing 10mL TMB chromogen.11.Stop Solution HRP: 1 bottle containing 10mL of 0.344M Sulfuric Acid. MVM Autoantibodies, Endomysial(Tissue Transglutaminase) 2 QUANTA LITE® R h-tTG IgA ELISA Kit, Bulk (Lab Corp)
18 08426950554509 701101 1. QUANTA Flash h-tTG IgA Calibrator 1: Two (2) barcode labeled tubes containing 1. QUANTA Flash h-tTG IgA Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human IgA antibodies to h-tTG in stabilizers and preservatives. 2. QUANTA Flash h-tTG IgA Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human IgA antibodies to h-tTG in stabilizers and preservatives. JIX Calibrator, Multi-Analyte Mixture 2 QUANTA Flash® h-tTG IgA Calibrators
19 08426950544470 701103 1. 1 QUANTA Flash h-tTG IgA reagent cartridge2. 1 Resuspension buffer 3. 1 Transfer pipet MVM Autoantibodies, Endomysial(Tissue Transglutaminase) 2 QUANTA Flash® h-tTG IgA Reagents
20 08426950544463 704605 1. Instruction leaflet: Giving full assay details.2.QC Certificate: Indicating t 1. Instruction leaflet: Giving full assay details.2.QC Certificate: Indicating the expected performance of the batch.3. Human Transglutaminase Coated Wells: 12 breakapart 8 well strips coated with recombinant tTG. Each plate is packaged in a re-sealable foil bag containing two desiccant pouches.4. HRP Sample Diluent: 2 bottles containing 50mL of buffer for sample dilution. Colored pink, ready to use.5. HRP Wash Concentrate: 1 bottle containing 25mL of a 40-fold concentrated buffer for washing the wells.6. R h-tTG IgA Calibrators: 5 bottles, each containing 1.2mL of diluted human serum, with the following concentrations of anti-tTG IgA autoantibody: 100, 33.3, 11.1, 3.7, 1.23 U/mL. Ready to use.7.R h-tTG IgA Positive Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.8.ELISA Negative Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.9. HRP R h-tTG IgA Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgA. Colored yellow. Ready to use.10. TMB Chromogen: 1 bottle containing 10mL TMB chromogen. Ready to use.11.Stop Solution HRP: 1 bottle containing 10mL of 0.344M Sulfuric Acid. Ready to use. MVM Autoantibodies, Endomysial(Tissue Transglutaminase) 2 QUANTA Lite® R h-tTG IgA ELISA
21 08426950544241 704660 "1. Instruction leaflet: 2. QC Certificate3. PR3 SC Coated Wells: 12 breakapar "1. Instruction leaflet: 2. QC Certificate3. PR3 SC Coated Wells: 12 breakapart 8 well strips 4. Type III Sample Diluent: 2 bottles containing 50mL 5. HRP Wash Concentrate: 1 bottle containing 25mL6. PR3 SC ELISA Calibrators: 5 bottles each containing 1.2mL 7. PR3 SC Positive Control: 1 bottle containing 1.2mL 8. ELISA Negative Control: 1 bottle containing 1.2mL 9. HRP PR3 SC IgG Conjugate: 1 bottle containing 10mL 10. TMB Chromogen: 1 bottle containing 10mL 11. HRP Stop Solution: 1 bottle containing 10mL MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca) 2 QUANTA Lite® PR3 SC ELISA
22 08426950544142 704610 1. Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating 1. Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating the expected performance of the batch.3. Human Transglutaminase Coated Wells: 12 breakapart 8 well strips coated with recombinant tTG. Each plate is packaged in a re-sealable foil bag containing two desiccant pouches.4. HRP Sample Diluent: 2 bottles containing 50mL of buffer for sample dilution. Colored pink, ready to use.5. HRP Wash Concentrate: 1 bottle containing 25mL of a 40-fold concentrated buffer for washing the wells.6. R h-tTG IgG Calibrators: 5 bottles, each containing 1.2mL of diluted human serum, with the following concentrations of anti-tTG IgG autoantibody: 100, 33.3, 11.1, 3.7, 1.23 U/mL. Ready to use.7. R h-tTG IgG Positive Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.8. ELISA Negative Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.9. HRP R h-tTG IgG Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgG. Colored blue. Ready to use.10. TMB Chromogen: 1 bottle containing 10mL TMB chromogen. Ready to use.11. Stop Solution: 1 bottle containing 10mL of 0.344M Sulfuric Acid. Ready to use. MVM Autoantibodies, Endomysial(Tissue Transglutaminase) 2 QUANTA Lite® R h-tTG IgG ELISA
23 08426950544111 704650 1.Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating t 1.Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating the expected performance of the batch.3. dsDNA SC Coated Wells: 12 breakapart 8 well strips coated with calf thymus dsDNA antigen. Each plate is packaged in a re-sealable foil bag containing two desiccant pouches.4. ELISA Negative Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.5. dsDNA SC Calibrators: 5 bottles, each containing 1.2mL of diluted human serum, with the following concentrations of anti-dsDNA autoantibody: 1000, 333, 111, 37, 12.3 IU/mL. Ready to use.6. dsDNA SC Positive Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.7. Type III Sample Diluent: 2 bottles containing 50mL of buffer for sample dilution. Colored yellow, ready to use.8. HRP Wash Concentrate (40X): 1 bottle containing 25mL of a 40-fold concentrated buffer for washing the wells.9.dsDNA SC Single Stranded Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.10. HRP dsDNA SC IgG Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgG. Colored blue. Ready to use.11. TMB Chromogen: 1 bottle containing 10mL TMB chromogen. Ready to use.12. HRP Stop Solution: 1 bottle containing 10mL of 0.344M Sulfuric Acid. Ready to use. LRM Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control 2 QUANTA Lite® dsDNA SC ELISA
24 08426950472773 708625 1. 1x Cardiolipin ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL 1. 1x Cardiolipin ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ACA Negative Control 3. 1x 1.2mL prediluted ACA IgG III Control4. 1x 1.2mL prediluted ACA IgG III Calibrator A5. 1x 1.2mL prediluted ACA IgG III Calibrator B6. 1x 1.2mL prediluted ACA IgG III Calibrator C7. 1x 1.2mL prediluted ACA IgG III Calibrator D8. 1x 1.2mL prediluted ACA IgG III Calibrator E9. 1x 50mL ACA III Sample Diluent10. 1x 50mL ACA III PBS Concentrate, 20x concentrate11. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG12. 1x 10mL TMB Chromogen13. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid MID System, Test, Anticardiolipin Immunological 2 QUANTA Lite® ACA IgG III
25 08426950456186 708580 1. 1x Scl-70 ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL pred 1. 1x Scl-70 ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted Scl-70 ELISA Low Positive4. 1x 1.2mL prediluted Scl-70 ELISA High Positive5. 1x 50mL HRP Sample Diluent 6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid LLL Extractable Antinuclear Antibody, Antigen And Control 2 QUANTA Lite® Scl-70 ELISA
26 08426951289288 701225 1. 1 QUANTA Flash aCL IgA Reagent Cartridge2. 1 QUANTA Flash aCL IgA Calibrator 1. 1 QUANTA Flash aCL IgA Reagent Cartridge2. 1 QUANTA Flash aCL IgA Calibrator 1 3. 1 QUANTA Flash aCL IgA Calibrator 2 MID System, Test, Anticardiolipin Immunological 2 QUANTA Flash® aCL IgA Reagents
27 08426950928782 701352 1. QUANTA Flash Calprotectin Low Control: Two (2) barcode labeled tubes containi 1. QUANTA Flash Calprotectin Low Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain recombinant calprotectin with stabilizers and preservatives. 2. QUANTA Flash Calprotectin High Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain recombinant calprotectin with stabilizers and preservatives. JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 QUANTA Flash® Calprotectin Controls
28 08426950835196 701346 1. QUANTA Flash RF IgA Calibrator 1: Two (2) barcode labeled tubes containing 0. 1. QUANTA Flash RF IgA Calibrator 1: Two (2) barcode labeled tubes containing 0.3mL prediluted, ready to use reagent. Calibrators contain human antibodies to RF IgA in stabilizers and preservatives.2. QUANTA Flash RF IgA Calibrator 2: Two (2) barcode labeled tubes containing 0.3mL prediluted, ready to use reagent. Calibrators contain human antibodies to RF IgA in stabilizers and preservatives. JIT Calibrator, Secondary 2 QUANTA Flash RF IgA Calibrators
29 08426950627821 701255 1. 1 QUANTA Flash ENA7 Reagent Cartridge2. 1 Resuspension buffer3. 1 Transfer pipet" LLL Extractable Antinuclear Antibody, Antigen And Control 2 QUANTA Flash® ENA7 Reagents
30 08426950596813 701228 1 .1 QUANTA Flash aCL IgA Reagent Cartridge2.1 QUANTA Flash aCL IgA Calibrator 1 1 .1 QUANTA Flash aCL IgA Reagent Cartridge2.1 QUANTA Flash aCL IgA Calibrator 1 3.1 QUANTA Flash aCL IgA Calibrator 2 MID System, Test, Anticardiolipin Immunological 2 QUANTA Flash® aCL IgA Reagents
31 08426950596653 701261 1. QUANTA Flash Ro52 Calibrator 1: Two (2) barcode labeled tubes containing 0.3 1. QUANTA Flash Ro52 Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to Ro52 in stabilizers and preservatives. 2. QUANTA Flash Ro52 Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human antibodies to Ro52 in stabilizers and preservatives. JIT Calibrator, Secondary 2 QUANTA Flash® Ro52 Calibrators
32 08426950596097 701197 1. QUANTA Flash Centromere Negative Control: Two (2) barcode labeled tubes conta 1. QUANTA Flash Centromere Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to centromere in buffer, stabilizers, and preservatives.2. QUANTA Flash Centromere Positive Control: Two (2) barcode labeled tubes containing 0.5mL, ready to use reagent. Controls contain human antibodies to centromere in buffer, stabilizers, and preservatives. JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 QUANTA Flash® Centromere Controls
33 08426950595816 708665.10 1. 10 B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL pre 1. 10 B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted 2 GPI IgG ELISA Control4. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator A5. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator B6. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator C7. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator D8. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator E9. 9x 50mL HRP Sample Diluent10. 10x 25mL HRP Wash Concentrate, 40x concentrate11. 10x 10mL 2 HRP IgG Conjugate, (goat), anti-human IgG12. 10x 10mL TMB Chromogen13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) 2 QUANTA Lite® β2GPI IgG ELISA Bulk Pack
34 08426950595038 701252 1. QUANTA Flash ß2GP1 IgM Low Control 3 x 1 mL barcoded tubes of a solution with 1. QUANTA Flash ß2GP1 IgM Low Control 3 x 1 mL barcoded tubes of a solution with anti-ß2GP1 IgM in phosphate buffer containing bovine serum albimun, stabilizers and preservative.2. QUANTA Flash ß2GP1 IgM High Control 3 x 1 mL barcoded tubes of a solution with anti-ß2GP1 IgM in phosphate buffer containing bovine serum albumin, stabilizers and preservative. JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 QUANTA Flash® β2GPI IgM Controls
35 08426950595632 701198 1. 1 QUANTA Flash Centromere Reagent Cartridge2. 1 Resuspension buffer 3. 1 Transfer pipet LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls 2 QUANTA Flash® Centromere Reagents
36 08426950594635 708625.10 1. 10x ACA IgG III ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2 1. 10x ACA IgG III ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ACA Negative Control 3. 5x 1.2mL prediluted ACA IgG III Control4. 5x 1.2mL prediluted ACA IgG III Calibrator A5. 5x 1.2mL prediluted ACA IgG III Calibrator B6. 5x 1.2mL prediluted ACA IgG III Calibrator C7. 5x 1.2mL prediluted ACA IgG III Calibrator D8. 5x 1.2mL prediluted ACA IgG III Calibrator E9. 9x 50mL ACA III Sample Diluent10. 10x 50mL ACA III PBS Concentrate, 20x concentrate11. 10x 10mL ACA IgG III Conjugate, (goat), anti-human IgG12. 10x 10mL TMB Chromogen13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid MID System, Test, Anticardiolipin Immunological 2 QUANTA Lite® ACA IgG III ELISA Bulk Pack
37 08426950594628 708990 1. 1x sp100 ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL predi 1. 1x sp100 ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted sp100 ELISA Low Positive4. 1x 1.2mL prediluted sp100 ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid NUM Autoantibodies, Nuclear Body Protein, Sp100 2 QUANTA Lite® sp100 ELISA
38 08426950544258 701138 1. 1 QUANTA Flash PR3 Reagent Cartridge MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca) 2 QUANTA Flash® PR3 Reagents
39 08426950594543 708665.10L 1. 10 B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL pre 1. 10 B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted 2 GPI IgG ELISA Control4. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator A5. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator B6. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator C7. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator D8. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator E9. 9x 50mL HRP Sample Diluent10. 10x 25mL HRP Wash Concentrate, 40x concentrate11. 10x 10mL 2 HRP IgG Conjugate, (goat), anti-human IgG12. 10x 10mL TMB Chromogen13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid MSV System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) 2 QUANTA LITE® B2 GPI IgG ELISA Bulk Pack Kit (Lab Corp)
40 08426950594512 704655.10 1. Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating 1. Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating the expected performance of the batch.3. MPO SC Coated Wells: 10 plates containing 12 breakapart 8 well strips coated with MPO antigen, colour coded green. Each plate is packaged in a re-sealable foil bag containing 2 desiccant pouches.4. Type III Sample Diluent: 19 bottles containing 50mL of buffer for sample dilution. Coloured yellow, ready to use.5. HRP Wash Concentrate: 10 bottles containing 25mL of a 40-fold concentrated buffer for washing the wells. 6. MPO SC ELISA Calibrators: 25 bottles (5 bottles each) containing 1.2mL of diluted human serum, with the following concentrations of anti-MPO autoantibody: 100, 33.3, 11.1, 3.7, 1.23 U/mL. Ready to use.7.MPO SC Positive Control: 5 bottles containing 1.2mL of diluted human serum. The expected value is given on the QC certificate.Ready to use.8. ELISA Negative Control: 5 bottles containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.9. HRP MPO SC IgG Conjugate: 10 bottles containing 10mL of purified peroxidase labelled antibody to human IgG. Coloured blue, ready to use.10. TMB Chromogen: 10 bottles containing 10mL TMB substrate. Ready to use.11.HRP Stop Solution: 10 bottles containing 10mL of 0.344M Sulfuric acid. Ready to use. MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca) 2 QUANTA Lite® MPO SC ELISA Bulk Pack
41 08426950593256 708715 1. 1x H. pylori IgG ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2 1. 1x H. pylori IgG ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted H. pylori IgG ELISA Low Positive4. 1x 1.2mL prediluted H. pylori IgG ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid LYR Helicobacter Pylori 1 QUANTA Lite® H.pylori IgG ELISA
42 08426950594079 704520.10 1. 10x Gliadin IgG II ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1. 10x Gliadin IgG II ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted Gliadin IgG II ELISA Low Positive4. 5x 1.2mL prediluted Gliadin IgG II ELISA High Positive5. 9 x50mL HRP Sample Diluent6. 10x 25mL HRP Wash Concentrate, 40x concentrate7. 10x 10mL HRP IgG Conjugate, (goat), anti-human IgG8. 10x 10mL TMB Chromogen9. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid MST Antibodies, Gliadin 2 QUANTA Lite® Gliadin IgG II ELISA Bulk Pack
43 08426950593706 708775 (Soluble Liver Antigen)1.1x SLA ELISA microwell plate (12-1 x 8 wells), with hol (Soluble Liver Antigen)1.1x SLA ELISA microwell plate (12-1 x 8 wells), with holder2.1x 1.2mL prediluted ELISA Negative Control 3.1x 1.2mL prediluted SLA ELISA Low Positive4.1x 1.2mL prediluted SLA ELISA High Positive5.1x 50mL HRP Sample Diluent 6.1x 25mL HRP Wash Concentrate, 40x concentrate7.1x 10mL HRP IgG Conjugate, (goat), anti-human IgG8.1x 10mL TMB Chromogen9.1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid NIY Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis 2 QUANTA Lite® SLA ELISA
44 08426950593461 708101 1. 5 x 12-well HEp-2 Substrate Slides2. 1 x 4mL FITC Anti-Human IgG Conjugate3. 1. 5 x 12-well HEp-2 Substrate Slides2. 1 x 4mL FITC Anti-Human IgG Conjugate3. 1 x 0.5 mL ANA Titratable Endpoint Pattern Control4. 1 x 0.5mL IFA System Negative Control5. 1 x 25mL PBS II Concentrate (40x)6. 1 x 7mL Mounting Medium7. 1 x 20 Coverslips LLL Extractable Antinuclear Antibody, Antigen And Control 2 NOVA Lite® HEp-2 ANA Kit
45 08426950593430 704630 1. Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating 1. Instruction leaflet: Giving full assay details.2. QC Certificate: Indicating the expected performance of the batch.3. Phosphatidylserine Coated Wells: 12 breakapart 8 well strips coated with Phosphatidylserine antigen. Each plate is packaged in a re-sealable foil bag containing 2 desiccant pouches.4. PS Sample Diluent: 2 bottles containing 50mL of buffer for sample dilution. Coloured straw, ready to use.5. PBS Wash Concentrate (20x): 1 bottle containing 50mL of a 20-fold concentrated buffer for washing the wells. 6. Phosphatidylserine IgM ELISA Calibrators: 5 bottles each containing 1.2mL of diluted human serum, with the following concentrations of anti-Phosphatidylserine autoantibody: 100, 33.3, 11.1, 3.7, 1.23 MPS U/mL. Ready to use.7. Phosphatidylserine IgM Positive Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate.Ready to use.8. ELISA Negative Control: 1 bottle containing 1.2mL of diluted human serum. The expected value is given on the QC certificate. Ready to use.9. HRP Phosphatidylserine IgM Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgM. Coloured blue, ready to use.10. TMB Chromogen: 1 bottle containing 10mL TMB substrate. Ready to use.11. HRP Stop Solution: 1 bottle containing 10mL of 0.344M Sulfuric acid. Ready to use. MID System, Test, Anticardiolipin Immunological 2 QUANTA Lite® Phosphatidylserine IgM ELISA
46 08426950593324 704545 1. 1x Celiac DGP Screen ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1. 1x Celiac DGP Screen ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted Celiac DGP Screen ELISA Low Positive4. 1x 1.2mL prediluted Celiac DGP Screen ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP Ig G/A Conjugate, (goat), anti-human IgG and IgA8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid MST Antibodies, Gliadin 2 QUANTA Lite® Celiac DGP Screen ELISA
47 08426950566373 701258 1. 1 QUANTA Flash ENA7 Reagent Cartridge2. 1 Resuspension buffer3. 1 Transfer pipet" LLL Extractable Antinuclear Antibody, Antigen And Control 2 QUANTA Flash® ENA7 Reagents
48 08426950557579 701167 1. QUANTA Flash DGP IgA Calibrator 1: Two (2) barcode labeled tubes containing 0 1. QUANTA Flash DGP IgA Calibrator 1: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human IgA antibodies to DGP in buffer, protein stabilizers, and preservatives. 2. QUANTA Flash DGP IgA Calibrator 2: Two (2) barcode labeled tubes containing 0.3 mL prediluted, ready to use reagent. Calibrators contain human IgA antibodies to DGP in buffer, protein stabilizers, and preservatives. JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 QUANTA Flash® DGP IgA Controls
49 08426950554554 701137 1. QUANTA Flash PR3 Negative Control: Two (2) barcode labeled tubes with buffer 1. QUANTA Flash PR3 Negative Control: Two (2) barcode labeled tubes with buffer containing human serum antibodies to PR3, prediluted, ready to use, 0.5mL (containing buffer, protein stabilizers, and preservatives).2. QUANTA Flash PR3 Positive Control: Two (2) barcode labeled tubes with buffer containing human serum antibodies to PR3, prediluted, ready to use, 0.5mL (containing buffer, protein stabilizers, and preservatives). JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 QUANTA Flash® PR3 Controls
50 08426950506362 704555 1. 1x RNA Pol III ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL 1. 1x RNA Pol III ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted, ready to use, ELISA Negative Control 3. 1x 1.2mL prediluted, ready to use, RNA Pol III ELISA Low Positive4. 1x 1.2mL prediluted, ready to use, RNA Pol III ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid NYO Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody 2 QUANTA Lite® RNA Pol III ELISA
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25 07340058410158 FBGP100 FBGP100 DIASTAT anti-B2-Glycoprotein-1 IgM EURO-DIAGNOSTICA AB
26 07340058410141 FBGP200 FBGP200 DIASTAT anti-B2 Glycoprotein-1 IgG EURO-DIAGNOSTICA AB
27 07333066014760 DECC055330 DECC055330 EliA ß2-Glycoprotein I IgM Well EliA ß2-Glycoprotein I IgM Well PHADIA AB
28 07333066014753 DECC055320 DECC055320 EliA ß2-Glycoprotein I IgG Well EliA ß2-Glycoprotein I IgG Well PHADIA AB
29 07333066014746 DECC055310 DECC055310 EliA ß2-Glycoprotein I IgA Well EliA ß2-Glycoprotein I IgA Well PHADIA AB
30 04250289503099 7215US 7215US AESKULISA β2-Glyco-Check is a solid phase enzyme immunoassay employing native β2 AESKULISA β2-Glyco-Check is a solid phase enzyme immunoassay employing native β2glycoproteinI highly purified from human plasma for the combined quantitative and qualitative detection of IgA, IgG and IgM antibodies against β2-glycoprotein I in human serum. Anti-β2glycoprotein I antibodies recognize specific epitopes on human β2-glycoprotein I which are expressed only when β2-glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome (APS). AESKULISA® ß2-Glyco-Check AESKU.DIAGNOSTICS GMBH & CO. KG
31 04250289503082 7206US 7206US AESKULISA β2-Glyco-GM is a solid phase enzyme immunoassay employing native β2gly AESKULISA β2-Glyco-GM is a solid phase enzyme immunoassay employing native β2glycoproteinI highly purified from human plasma for the separate quantitative and qualitative detection of IgG and / or IgM antibodies against β2-glycoprotein I in human serum. Anti-β2glycoprotein I antibodies recognize specific epitopes on human β2-glycoprotein I which are expressed only when β2-glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome (APS). AESKULISA® ß2-Glyco-GM AESKU.DIAGNOSTICS GMBH & CO. KG
32 04250289503075 7205US 7205US AESKULISA b2 Glyco-A is a solid phase enzyme immunoassay employing native b2 gly AESKULISA b2 Glyco-A is a solid phase enzyme immunoassay employing native b2 glycoprotein I highly purified from human plasma for the semiquantitative and qualitative detection of IgA antibodies against ß2 glycoprotein I in human serum. The presence of anti-b2 glycoprotein I antibodies in conjuction with clinical findings and other laboratory results can be used as an aid in the diagnosis of thrombotic disorders related to primary andsecondary antiphospholipid syndrome. AESKULISA® ß2-Glyco-A AESKU.DIAGNOSTICS GMBH & CO. KG
33 04250289502849 30-7215US 30-7215US AESKULISA β2-Glyco-Check is a solid phase enzyme immunoassay employing native β2 AESKULISA β2-Glyco-Check is a solid phase enzyme immunoassay employing native β2glycoproteinI highly purified from human plasma for the combined quantitative and qualitative detection of IgA, IgG and IgM antibodies against β2-glycoprotein I in human serum. Anti-β2glycoprotein I antibodies recognize specific epitopes on human β2-glycoprotein I which are expressed only when β2-glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome (APS).30'+30'+30' automation incubation. AESKULISA® ß2-Glyco-Check AESKU.DIAGNOSTICS GMBH & CO. KG
34 04250289502832 30-7206US 30-7206US AESKULISA β2-Glyco-GM is a solid phase enzyme immunoassay employing native β2gly AESKULISA β2-Glyco-GM is a solid phase enzyme immunoassay employing native β2glycoproteinI highly purified from human plasma for the separate quantitative and qualitative detection of IgG and / or IgM antibodies against β2-glycoprotein I in human serum. Anti-β2glycoprotein I antibodies recognize specific epitopes on human β2-glycoprotein I which are expressed only when β2-glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome (APS).30'+30'+30' automation incubation. AESKULISA® ß2-Glyco-GM AESKU.DIAGNOSTICS GMBH & CO. KG
35 04250289502825 30-7205US 30-7205US AESKULISA β2 Glyco-A is a solid phase enzyme immunoassay employing native β2 gly AESKULISA β2 Glyco-A is a solid phase enzyme immunoassay employing native β2 glycoprotein I highly purified from human plasma for the quantitative and qualitative detection of IgA antibodies against β2 glycoprotein I in human serum. Anti-β2 glycoprotein I antibodies recognize specific epitopes on human β2 glycoprotein I which are expressed only when β2 glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome. 30'+30'+30' automation incubation. AESKULISA® ß2-Glyco-A AESKU.DIAGNOSTICS GMBH & CO. KG
36 04250289500951 3215 AESKULISA β2-Glyco-Check is a solid phase enzyme immunoassay employing native β2 AESKULISA β2-Glyco-Check is a solid phase enzyme immunoassay employing native β2glycoproteinI highly purified from human plasma for the combined quantitative and qualitative detection of IgA, IgG and IgM antibodies against β2-glycoprotein I in human serum. Anti-β2glycoprotein I antibodies recognize specific epitopes on human β2-glycoprotein I which are expressed only when β2-glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome (APS). AESKULISA® ß2-Glyco-Check AESKU.DIAGNOSTICS GMBH & CO. KG
37 04250289500869 3206 AESKULISA β2-Glyco-GM is a solid phase enzyme immunoassay employing native β2gly AESKULISA β2-Glyco-GM is a solid phase enzyme immunoassay employing native β2glycoproteinI highly purified from human plasma for the separate quantitative and qualitative detection of IgG and / or IgM antibodies against β2-glycoprotein I in human serum. Anti-β2glycoprotein I antibodies recognize specific epitopes on human β2-glycoprotein I which are expressed only when β2-glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome (APS). AESKULISA® ß2-Glyco-GM AESKU.DIAGNOSTICS GMBH & CO. KG
38 04250289500852 3205 AESKULISA β2 Glyco-A is a solid phase enzyme immunoassay employing native β2 gly AESKULISA β2 Glyco-A is a solid phase enzyme immunoassay employing native β2 glycoprotein I highly purified from human plasma for the quantitative and qualitative detection of IgA antibodies against β2 glycoprotein I in human serum. Anti-β2 glycoprotein I antibodies recognize specific epitopes on human β2 glycoprotein I which are expressed only when β2 glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome. AESKULISA® ß2-Glyco-A AESKU.DIAGNOSTICS GMBH & CO. KG
39 00855360006236 11854 11854 INTENDED USEAn enzyme-linked immunoassay (ELISA) for the detection of IgG antibo INTENDED USEAn enzyme-linked immunoassay (ELISA) for the detection of IgG antibodies to complexes formed byoxidized low-density lipoprotein (oxLDL) with β2-glycoprotein I (β2GPI) in individuals with systemic lupuserythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome). For In Vitro Diagnostic Use Only.SUMMARY AND EXPLANATION OF THE ASSAYThe antiphospholipid syndrome (APS) is one of the most common causes of acquired hypercoagulability(thrombophilia) It is frequently diagnosed in the context of a systemic autoimmune disorder such asSLE (secondary APS), however, it may also occur in the absence of an obvious underlying disease(primary APS). Oxidative stress and oxLDL formation are common in patients with SLE and APS suggesting an important relationship between lipid peroxidation and clotting activation (hypercoagulability). The presence of circulating IgG anti-oxLDL-β2GPI antibodies seem to be etiologically important. PRINCIPLE OF THE TESTThis test is an indirect ELISA detecting IgG anti-oxLDL-β2GPI antibodies. Diluted serum samples, calibrator(s), and controls are incubated in microwells coated with the oxLDL- β2GPI complex. After the removal of unbound serum proteins by washing, anti-human IgG antibodies, labeled with horseradish peroxidase (HRP), are added. Following another wash, the bound enzyme-antibody conjugate is assayed by the addition of tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of IgG anti-oxLDL-β2GPI antibody. Results are obtained by reading the OD of each well in a spectrophotometer. Calibrator sera are provided, with the IgG anti-oxLDL-β2GPI antibody concentration expressed in G Units. A log-log regression analysis is performed with calibrator values plotted against calibrator mean O.D.’s. Controls and patient results are determined from the calibration curve. Refer to product package insert. Anti-AtherOxTM IgG Test Kit (OxLDL-B2GPI IgG Antibody) CORGENIX MEDICAL CORPORATION
40 00855360006199 13372 13372 INTENDED USE For the detection and semi-quantitation of IgA anti-β2GPl antibodie INTENDED USE For the detection and semi-quantitation of IgA anti-β2GPl antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use.SUMMARY OF THE TEST Anti-phospholipid antibodies are a heterogeneous group of immunoglobulins that bind to several anionic phospholipids, including cardiolipin and phosphatidylserine. High serum levels of anti-phospholipid antibodies are frequently detected in patients with autoimmune (e.g., SLE) and non-autoimmune diseases, as well as in apparently healthy individuals. Patients with positive reactions to both anti-phospholipid and anti-β2GPl assays were more likely to have clinical complications than those positive for only one. Higher prevalence and mean serum levels of IgA anti-β2GPl antibodies have been reported in autoimmune patients. In addition, anti-β2GPl antibodies in SLE patients correlated with clinical manifestations of anti-phospholipid syndrome.PRINCIPLE OF THE TEST The test is an indirect ELISA. Diluted serum/plasma samples, calibrator sera, and controls are incubated in microwells coated with purified human β2GPl. After the removal of unbound serum or plasma proteins by washing, antibodies specific for human IgA, labeled with horseradish peroxidase (HRP), are added forming complexes with the β2GPl bound antibodies. Following another wash step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of anti-β2GPl antibodies. Results are obtained by reading the O.D. of each well in a spectrophotometer. Calibrator sera are provided, with the IgA anti-β2GPl antibody concentrations expressed in A units. Controls and patient results are determined from the calibration curve. Refer to product package insert. Corgenix Anti-Beta 2 Glycoprotein I IgA Semi-Quantitative Test Kit (192 Well) CORGENIX MEDICAL CORPORATION
41 00855360006182 13371 13371 INTENDED USE For the detection and semi-quantitation of IgM anti-β2GPl antibodie INTENDED USE For the detection and semi-quantitation of IgM anti-β2GPl antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use.SUMMARY OF THE TEST Anti-phospholipid antibodies are a heterogeneous group of immunoglobulins that bind to several anionic phospholipids, including cardiolipin and phosphatidylserine. High serum levels of anti-phospholipid antibodies are frequently detected in patients with autoimmune (e.g., SLE) and non-autoimmune diseases, as well as in apparently healthy individuals. Patients with positive reactions to both anti-phospholipid and anti-β2GPl assays were more likely to have clinical complications than those positive for only one. Higher prevalence and mean serum levels of IgM anti-β2GPl antibodies have been reported in autoimmune patients. In addition, anti-β2GPl antibodies in SLE patients correlated with clinical manifestations of anti-phospholipid syndrome.PRINCIPLE OF THE TEST The test is an indirect ELISA. Diluted serum/plasma samples, calibrator sera, and controls are incubated in microwells coated with purified human β2GPl.. After the removal of unbound serum or plasma proteins by washing, antibodies specific for human IgM, labeled with horseradish peroxidase (HRP), are added forming complexes with the β2GPl bound antibodies. Following another wash step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of anti-β2GPl antibodies. Results are obtained by reading the O.D. of each well in a spectrophotometer. Calibrator sera are provided, with the IgM anti-β2GPl antibody concentrations expressed in M units. Controls and patient results are determined from the calibration curve. Refer to Product package insert. Corgenix Anti-Beta 2 Glycoprotein I IgM Semi-Quantitative Test Kit (192 Well) CORGENIX MEDICAL CORPORATION
42 00855360006175 13370 13370 INTENDED USE For the detection and semi-quantitation of IgG anti-β2GPl antibodie INTENDED USE For the detection and semi-quantitation of IgG anti-β2GPl antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Use Only.SUMMARY AND EXPLANATION OF THE I TEST Anti-phospholipid antibodies are a heterogeneous group of immunoglobulins that bind to several anionic phospholipids, including cardiolipin and phosphatidylserine. High serum levels of anti-phospholipid antibodies are frequently detected in patients with autoimmune (e.g., SLE) and non-autoimmune diseases, as well as in apparently healthy individuals. Patients with positive reactions to both anti-phospholipid and anti-β2GPl assays were more likely to have clinical complications than those positive for only one. Higher prevalence and mean serum levels of IgG anti-β2GPl antibodies have been reported in autoimmune patients. In addition, anti-β2GPl antibodies in SLE patients correlated with clinical manifestations of anti-phospholipid syndrome. PRINCIPLE OF THE TEST The test is s an indirect ELISA. Diluted serum/ plasma samples, calibrator sera, and controls are incubated in microwells coated with purified human β2GPl. After the removal of unbound serum/plasma proteins by washing, antibodies specific for human IgG, labeled with horseradish peroxidase (HRP), are added forming complexes with the β2GPl bound antibodies. Following another wash step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at intensity proportional to the serum concentration of anti-β2GPl antibodies. Results are obtained by reading the O.D. of each well in a spectrophotometer. Calibrator sera are provided, with the IgG anti-β2GPl antibody concentrations expressed in G units.. Controls and patient results are determined from the calibration curve. Refer to Product Package Insert. Corgenix Anti-Beta 2 Glycoprotein I IgG Semi-Quantitative Test Kit (192 Well) CORGENIX MEDICAL CORPORATION
43 00855360006168 038-001 038-001 INTENDED USEFor the detection and semi-quantitation of IgM anti-β2GPl antibodies INTENDED USEFor the detection and semi-quantitation of IgM anti-β2GPl antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use.SUMMARY OF THE TESTAnti-phospholipid antibodies are a heterogeneous group of immunoglobulins that bind to several anionicphospholipids, including cardiolipin and phosphatidylserine. High serum levels of anti-phospholipid antibodies are frequently detected in patients with autoimmune (e.g., SLE) and non-autoimmune diseases, as well as in apparently healthy individuals. Patients with positive reactions to both anti-phospholipid and anti-β2GPl assays were more likely to have clinical complications than those positive for only one. Higher prevalence and mean serum levels of IgM anti-β2GPl antibodies have been reported in autoimmune patients. In addition, anti-β2GPl antibodies in SLE patients correlated with clinical manifestations of anti-phospholipid syndrome.PRINCIPLE OF THE TESTThe test is an indirect ELISA. Diluted serum/plasma samples, calibrator sera, and controls are incubated in microwells coated with purified human β2GPl. After the removal of unbound serum or plasma proteins by washing, antibodies specific for human IgM, labeled with horseradish peroxidase (HRP), are added forming complexes with the β2GPl bound antibodies. Following another wash step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of anti-β2GPl antibodies. Results are obtained by reading the O.D. of each well in a spectrophotometer. Calibrator sera are provided, with the IgM anti-β2GPl antibody concentrations expressed in M units. Controls and patient results are determined from the calibration curve. Refer to Product Package Insert. REAADS Anti-Beta 2 Glycoprotein I IgM Semi-Quantitative Test Kit (96 Well) CORGENIX MEDICAL CORPORATION
44 00855360006151 037-001 037-001 INTENDED USEFor the detection and semi-quantitation of IgG anti-β2GPl antibodies INTENDED USEFor the detection and semi-quantitation of IgG anti-β2GPl antibodies in individuals with systemic lupuserythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Use Only.SUMMARY OF THE TESTAnti-phospholipid antibodies are a heterogeneous group of immunoglobulins that bind to several anionic phospholipids, including cardiolipin and phosphatidylserine. High serum levels of anti-phospholipid antibodies are frequently detected in patients with autoimmune (e.g., SLE) and non-autoimmune diseases, as well as in apparently healthy individuals. Patients with positive reactions to both anti-phospholipid and anti-β2GPl assays were more likely to have clinical complications than those positive for only one. Higher prevalence and mean serum levels of IgG anti-β2GPl antibodies have been reported in autoimmune patients. In addition, anti-β2GPl antibodies in SLE patients correlated with clinical manifestations of anti-phospholipid syndrome.PRINCIPLE OF THE TESTThe test is an indirect ELISA. Diluted serum/plasma samples, calibrator sera, and controls are incubated in microwells coated with purified human β2GPl. After the removal of unbound serum or plasma proteins by washing, antibodies specific for human IgG, labeled with horseradish peroxidase (HRP), are added forming complexes with the β2GPl bound antibodies. Following another wash step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of anti-β2GPl antibodies. Results are obtained by reading the O.D. of each well in a spectrophotometer. Calibrator sera are provided, with the IgG anti-β2GPl antibody concentrations expressed in G units. Controls and patient results are determined from the calibration curve. Refer to Product Package Insert. REAADS Anti-Beta 2 Glycoprotein I IgG Semi-Quantitative Test Kit (96 Well) CORGENIX MEDICAL CORPORATION
45 00855360006144 039-001 039-001 INTENDED USEFor the detection and semi-quantitation of IgA anti-β2GPl antibodies INTENDED USEFor the detection and semi-quantitation of IgA anti-β2GPl antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Use Only.SUMMARY OF THE TESTAnti-phospholipid antibodies are a heterogeneous group of immunoglobulins that bind to several anionic phospholipids, including cardiolipin and phosphatidylserine. High serum levels of anti-phospholipid antibodies are frequently detected in patients with autoimmune (e.g., SLE) and non-autoimmune diseases, as well as in apparently healthy individuals. Patients with positive reactions to both anti-phospholipid and anti-β2GPl assays were more likely to have clinical complications than those positive for only one. Higher prevalence and mean serum levels of IgA anti-β2GPl antibodies have been reported in autoimmune patients. In addition, anti-β2GPl antibodies in SLE patients correlated with clinical manifestations of anti-phospholipid syndrome.PRINCIPLE OF THE TESTThe test is an indirect ELISA. Diluted serum/plasma samples, calibrator sera, and controls are incubated in microwells coated with purified human β2GPl. After the removal of unbound serum or plasma proteins by washing, antibodies specific for human IgA, labeled with horseradish peroxidase (HRP), are added forming complexes with the β2GPl bound antibodies. Following another wash step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of anti-β2GPl antibodies. Results are obtained by reading the O.D. of each well in a spectrophotometer. Calibrator sera are provided, with the IgA anti-β2GPl antibody concentrations expressed in A units. Controls and patient results are determined from the calibration curve. Refer to Product Package Insert. REAADS Anti-Beta 2 Glycoprotein I IgA Semi-Quantitative Test Kit (96 Well) CORGENIX MEDICAL CORPORATION
46 00847865012997 SW4.1_1 6652165B Manual & CDs, APLS IgA IFU, SW4.1_v1, US Only BioPlex 2200 BIO-RAD LABORATORIES, INC.
47 00847865012980 SW4.1V1 6652065B Manual & CDs, APLS IgM IFU, SW4.1_v1 BioPlex 2200 BIO-RAD LABORATORIES, INC.
48 00847865012973 SW4.1V1 6651975B APLS IgG, IgM and IgA Assay Protocol File CD, SW4.1_v1 US Only BioPlex 2200 BIO-RAD LABORATORIES, INC.
49 00847865012966 SW4.1V1 6651965B Manual & CDs, APLS IgG IFU, SW4.1_v1, US Only BioPlex 2200 BIO-RAD LABORATORIES, INC.
50 00847865012522 SW4_1 6651965A Manual & CDs, BioPlex 2200 APLS IgG IFU, SW4_v1, US Only BioPlex 2200 BIO-RAD LABORATORIES, INC.