Other products from "PHADIA AB"
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 07333066022307 34-2317-93 34-2317-93 Phadia Maintenance Solution Small JJE ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE 1 Phadia Maintenance Solution Small
2 07333066019994 83-0008-01 83-0008-01 EliA APS Positive Control 250 JJY Multi-analyte controls, all kinds (assayed) 1 EliA APS Positive Control 250
3 07333066019987 83-0007-91 83-0007-91 EliA APS Positive Control 100 JJY Multi-analyte controls, all kinds (assayed) 1 EliA APS Positive Control 100
4 07333066019970 83-0006-71 83-0006-71 EliA Celiac Positive Control 250 JJY Multi-analyte controls, all kinds (assayed) 1 EliA Celiac Positive Control 250
5 07333066019963 34-2341-31 34-2341-31 ImmunoCAP Specific IgE Control H DHB System, test, radioallergosorbent (rast) immunological 2 ImmunoCAP Specific IgE Control H
6 07333066019949 34-2341-11 34-2341-11 ImmunoCAP Specific IgE Control L DHB System, test, radioallergosorbent (rast) immunological 2 ImmunoCAP Specific IgE Control L
7 07333066019857 34-2325-31 34-2325-31 ImmunoCAP Autoimmunity Specific IgG Sample Diluent JJY Multi-analyte controls, all kinds (assayed) 1 ImmunoCAP Autoimmunity Specific IgG Sample Diluent
8 07333066019840 34-2316-11 34-2316-11 ImmunoCAP Autoimmunity Specific IgG Sample Diluent JJY Multi-analyte controls, all kinds (assayed) 1 ImmunoCAP Autoimmunity Specific IgG Sample Diluent
9 07333066019826 34-2294-41 34-2294-41 ImmunoCAP Specific IgG Conjugate JJY Multi-analyte controls, all kinds (assayed) 1 ImmunoCAP Specific IgG Conjugate
10 07333066019628 10-9414-01 10-9414-01 Contains 2 vials of each IgG antibodies level (N: normal; L: low; H: high) for t Contains 2 vials of each IgG antibodies level (N: normal; L: low; H: high) for the ImmunoCAP Thyroid Peroxidase method. JJY Multi-analyte controls, all kinds (assayed) 1 ImmunoCAP Thyroid Peroxidase IgG Antibodies Control NLH
11 07333066014807 DECC055390 DECC055390 EliA GliadinDP IgG Well MST Antibodies, gliadin 2 EliA GliadinDP IgG Well
12 07333066017549 14-6016-01 14-6016-01 ImmunoCAP Allergen i216, Allergen component rApi m 5, Honey bee PUW System, test, radioallergosorbent (Rast) immunological, exempt allergens 2 ImmunoCAP Allergen i216, Allergen component rApi m 5, Honey bee
13 07333066017532 14-6015-01 14-6015-01 ImmunoCAP Allergen i215, Allergen component rApi m 3, Honey bee PUW System, test, radioallergosorbent (Rast) immunological, exempt allergens 2 ImmunoCAP Allergen i215, Allergen component rApi m 3, Honey bee
14 07333066014852 DECC056490 DECC056490 EliA M2 Well DBM ANTIMITOCHONDRIAL ANTIBODY, INDIRECT IMMUNOFLUORESCENT, ANTIGEN, CONTROL 2 EliA M2 Well
15 07333066014746 DECC055310 DECC055310 EliA ß2-Glycoprotein I IgA Well MSV System,test,antibodies,b2 - glycoprotein i (b2 - gpi) 2 EliA ß2-Glycoprotein I IgA Well
16 07333066014692 DECC055200 DECC055200 EliA Gliadin IgG Well MST Antibodies, gliadin 2 EliA Gliadin IgG Well
17 07333066013138 83-0008-51 83-0008-51 EliA IgM Conjugate 200 DHR SYSTEM, TEST, RHEUMATOID FACTOR 2 EliA IgM Conjugate 200
18 07333066013077 83-0007-21 83-0007-21 EliA Celiac Positive Control 100 JJY Multi-analyte controls, all kinds (assayed) 1 EliA Celiac Positive Control 100
19 07333066013060 83-0007-11 83-0007-11 EliA CCP Positive Control 100 NHX ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP) 2 EliA CCP Positive Control 100
20 07333066012841 83-0003-41 83-0003-41 EliA IgA Curve Control Strip MVM Autoantibodies, endomysial(tissue transglutaminase) 2 EliA IgA Curve Control Strip
21 07333066012780 83-0002-81 83-0002-81 EliA IgA Conjugate MVM Autoantibodies, endomysial(tissue transglutaminase) EliA IgA Conjugate
22 07333066011615 34-2273-31 34-2273-31 ImmunoCAP Specific IgG Curve Control Strip JJY Multi-analyte controls, all kinds (assayed) 1 ImmunoCAP Specific IgG Curve Control Strip
23 07333066010496 14-5341-01 14-5341-01 ImmunoCAP Allergen f352, Allergen component rAra h 8 PR-10, Peanut DHB SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL 2 ImmunoCAP Allergen f352, Allergen component rAra h 8 PR-10, Peanut
24 07333066009902 14-5304-10 14-5304-10 ImmunoCAP Antigen RGm24, Stachybotrys atra MVU Reagents, specific, analyte 1 ImmunoCAP Antigen RGm24, Stachybotrys atra
25 07333066009841 14-5301-10 14-5301-10 ImmunoCAP Rare Allergen Rm226, Staphylococcal enterotoxin TSST MVU Reagents, specific, analyte 1 ImmunoCAP Rare Allergen Rm226, Staphylococcal enterotoxin TSST
26 07333066009193 14-5254-10 14-5254-10 ImmunoCAP Allergen f335, Lupine seed MVU Reagents, specific, analyte 1 ImmunoCAP Allergen f335, Lupine seed
27 07333066009094 14-5249-10 14-5249-10 ImmunoCAP Rare Allergen Rf332, Mint MVU Reagents, specific, analyte 1 ImmunoCAP Rare Allergen Rf332, Mint
28 07333066008424 14-5209-10 14-5209-10 ImmunoCAP Allergen Rf313, Anchovy MVU Reagents, specific, analyte 1 ImmunoCAP Allergen Rf313, Anchovy
29 07333066008363 14-5206-10 14-5206-10 ImmunoCAP Allergen Rfx21, Fruits MVU Reagents, specific, analyte 1 ImmunoCAP Allergen Rfx21, Fruits
30 07333066008288 14-5202-10 14-5202-10 ImmunoCAP Allergen Rm208, Chaetomium globosum MVU Reagents, specific, analyte 1 ImmunoCAP Allergen Rm208, Chaetomium globosum
31 07333066008059 14-5189-10 14-5189-10 ImmunoCAP Rare Allergen Rk209, Hexalhydrophtalic anhydrid MVU Reagents, specific, analyte 1 ImmunoCAP Rare Allergen Rk209, Hexalhydrophtalic anhydrid
32 07333066007953 14-5183-10 14-5183-10 ImmunoCAP Allergen Rtx10, Tree pollen MVU Reagents, specific, analyte 1 ImmunoCAP Allergen Rtx10, Tree pollen
33 07333066007496 14-5139-10 14-5139-10 ImmunoCAP Rare Allergen Rf298, Tragacanth MVU Reagents, specific, analyte 1 ImmunoCAP Rare Allergen Rf298, Tragacanth
34 07333066006925 14-5086-10 14-5086-10 ImmunoCAP Allergen Rf212, Mushroom (champignon) MVU Reagents, specific, analyte 1 ImmunoCAP Allergen Rf212, Mushroom (champignon)
35 07333066006642 14-5065-10 14-5065-10 ImmunoCAP Allergen Rf221, Coffee MVU Reagents, specific, analyte 1 ImmunoCAP Allergen Rf221, Coffee
36 07333066006628 14-5064-10 14-5064-10 ImmunoCAP Allergen Rf268, Clove MVU Reagents, specific, analyte 1 ImmunoCAP Allergen Rf268, Clove
37 07333066006574 14-5060-10 14-5060-10 ImmunoCAP Allergen Rf291, Cauliflower MVU Reagents, specific, analyte 1 ImmunoCAP Allergen Rf291, Cauliflower
38 07333066006352 14-5044-10 14-5044-10 ImmunoCAP Allergen Rf271, Anise MVU Reagents, specific, analyte 1 ImmunoCAP Allergen Rf271, Anise
39 07333066006147 14-5026-10 14-5026-10 ImmunoCAP Allergen wx209, Ambrosia sp. MVU Reagents, specific, analyte 1 ImmunoCAP Allergen wx209, Ambrosia sp.
40 07333066005768 14-4990-01 14-4990-01 ImmunoCAP Allergen f431, Allergen component nGly m 5 Beta-conglycinin, Soy DHB SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL 2 ImmunoCAP Allergen f431, Allergen component nGly m 5 Beta-conglycinin, Soy
41 07333066005713 14-4983-01 14-4983-01 ImmunoCAP Allergen w233, Allergen component nArt v 3 LTP, Mugwort DHB SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL 2 ImmunoCAP Allergen w233, Allergen component nArt v 3 LTP, Mugwort
42 07333066005638 14-4972-01 14-4972-01 ImmunoCAP Allergen g216, Allergen component nCyn d 1 Bermuda grass DHB SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL 2 ImmunoCAP Allergen g216, Allergen component nCyn d 1 Bermuda grass
43 07333066005539 14-4963-01 14-4963-01 ImmunoCAP Allergen f422, Allergen component rAra h 1 Peanut DHB SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL 2 ImmunoCAP Allergen f422, Allergen component rAra h 1 Peanut
44 07333066005508 14-4960-01 14-4960-01 ImmunoCAP Allergen f419, Allergen component rPru p 1 PR-10, Peach DHB SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL 2 ImmunoCAP Allergen f419, Allergen component rPru p 1 PR-10, Peach
45 07333066005386 14-4950-10 14-4950-10 ImmunoCAP Allergen Rw23, Yellow dock MVU Reagents, specific, analyte 1 ImmunoCAP Allergen Rw23, Yellow dock
46 07333066004556 14-4843-01 14-4843-01 ImmunoCAP Allergen f299, Sweet chestnut DHB SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL 2 ImmunoCAP Allergen f299, Sweet chestnut
47 07333066004488 14-4836-01 14-4836-01 ImmunoCAP Allergen f203, Pistachio DHB SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL 2 ImmunoCAP Allergen f203, Pistachio
48 07333066004327 14-4820-01 14-4820-01 ImmunoCAP Allergen f207, Clam DHB SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL 2 ImmunoCAP Allergen f207, Clam
49 07333066004303 14-4818-01 14-4818-01 ImmunoCAP Allergen f284, Turkey meat DHB SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL 2 ImmunoCAP Allergen f284, Turkey meat
50 07333066003801 14-4434-01 14-4434-01 ImmunoCAP Allergen f254, Plaice DHB SYSTEM, TEST, RADIOALLERGOSORBENT (RAST) IMMUNOLOGICAL 2 ImmunoCAP Allergen f254, Plaice
Other products with the same Product Code "MID"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 08426951289295 701230 1. 1 QUANTA Flash aCL IgG Reagent Cartridge2. 1 QUANTA Flash aCL IgG Calibrator 1. 1 QUANTA Flash aCL IgG Reagent Cartridge2. 1 QUANTA Flash aCL IgG Calibrator 1 3. 1 QUANTA Flash aCL IgG Calibrator 2 QUANTA Flash® aCL IgG Reagents INOVA DIAGNOSTICS, INC.
2 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 QUANTA Flash® aCL IgA Reagents INOVA DIAGNOSTICS, INC.
3 08426951289240 701235 1. 1 QUANTA Flash aCL IgM Reagent Cartridge2. 1 QUANTA Flash aCL IgM Calibrator 1. 1 QUANTA Flash aCL IgM Reagent Cartridge2. 1 QUANTA Flash aCL IgM Calibrator 1 3. 1 QUANTA Flash aCL IgM Calibrator 2 QUANTA Flash® aCL IgM Reagents INOVA DIAGNOSTICS, INC.
4 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 QUANTA Flash® aCL IgA Reagents INOVA DIAGNOSTICS, INC.
5 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. QUANTA Lite® Phosphatidylserine IgG ELISA Bulk Pack INOVA DIAGNOSTICS, INC.
6 08426950595601 704635.10 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 IgA 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 IgA 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 IgA Conjugate: 10 bottles containing 10mL of purified peroxidase labelled antibody to human IgA. Coloured green, 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. QUANTA Lite® Phosphatidylserine IgA ELISA Bulk Pack INOVA DIAGNOSTICS, INC.
7 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. QUANTA Lite® Phosphatidylserine IgM ELISA Bulk Pack INOVA DIAGNOSTICS, INC.
8 08426950594666 708635.10 1. 10x ACA IgA III ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2 1. 10x ACA IgA III ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ACA Negative Control 3. 5x 1.2mL prediluted ACA IgA III Control4. 5x 1.2mL prediluted ACA IgA III Calibrator A5. 5x 1.2mL prediluted ACA IgA III Calibrator B6. 5x 1.2mL prediluted ACA IgA III Calibrator C7. 5x 1.2mL prediluted ACA IgA III Calibrator D8. 5x 1.2mL prediluted ACA IgA III Calibrator E9. 9x 50mL ACA III Sample Diluent10. 10x 50mL ACA III PBS Concentrate, 20x concentrate11. 10x 10mL ACA IgA III Conjugate, (goat), anti-human IgA12. 10x 10mL TMB Chromogen13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid QUANTA Lite® ACA IgA III ELISA Bulk Pack INOVA DIAGNOSTICS, INC.
9 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 QUANTA Lite® ACA IgG III ELISA Bulk Pack INOVA DIAGNOSTICS, INC.
10 08426950594536 708630.10 1. 10x ACA IgM III ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2 1. 10x ACA IgM III ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ACA Negative Control 3. 5x 1.2mL prediluted ACA IgM III Control4. 5x 1.2mL prediluted ACA IgM III Calibrator A5. 5x 1.2mL prediluted ACA IgM III Calibrator B6. 5x 1.2mL prediluted ACA IgM III Calibrator C7. 5x 1.2mL prediluted ACA IgM III Calibrator D8. 5x 1.2mL prediluted ACA IgM III Calibrator E9. 9x 50mL ACA III Sample Diluent10. 10x 50mL ACA III PBS Concentrate, 20x concentrate11. 10x 10mL HRP ACA IgM Conjugate, (goat), anti-human IgM12. 10x 10mL TMB Chromogen13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid QUANTA Lite® ACA IgM III ELISA Bulk Pack INOVA DIAGNOSTICS, INC.
11 08426950594178 708635.10L 1. 10x ACA IgA III ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2 1. 10x ACA IgA III ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ACA Negative Control 3. 5x 1.2mL prediluted ACA IgA III Control4. 5x 1.2mL prediluted ACA IgA III Calibrator A5. 5x 1.2mL prediluted ACA IgA III Calibrator B6. 5x 1.2mL prediluted ACA IgA III Calibrator C7. 5x 1.2mL prediluted ACA IgA III Calibrator D8. 5x 1.2mL prediluted ACA IgA III Calibrator E9. 9x 50mL ACA III Sample Diluent10. 10x 50mL ACA III PBS Concentrate, 20x concentrate11. 10x 10mL ACA IgA III Conjugate, (goat), anti-human IgA12. 10x 10mL TMB Chromogen13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid QUANTA LITE® ACA IgA III ELISA Bulk Pack Kit (Lab Corp) INOVA DIAGNOSTICS, INC.
12 08426950594123 708625.10L 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 QUANTA LITE® ACA IgG III ELISA Bulk Pack Kit (Lab Corp) INOVA DIAGNOSTICS, INC.
13 08426950594062 708630.10L 1. 10x ACA IgM III ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2 1. 10x ACA IgM III ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ACA Negative Control 3. 5x 1.2mL prediluted ACA IgM III Control4. 5x 1.2mL prediluted ACA IgM III Calibrator A5. 5x 1.2mL prediluted ACA IgM III Calibrator B6. 5x 1.2mL prediluted ACA IgM III Calibrator C7. 5x 1.2mL prediluted ACA IgM III Calibrator D8. 5x 1.2mL prediluted ACA IgM III Calibrator E9. 9x 50mL ACA III Sample Diluent10. 10x 50mL ACA III PBS Concentrate, 20x concentrate11. 10x 10mL HRP ACA IgM Conjugate, (goat), anti-human IgM12. 10x 10mL TMB Chromogen13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid QUANTA LITE® ACA IgM III ELISA Bulk Pack Kit (Lab Corp) INOVA DIAGNOSTICS, INC.
14 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. QUANTA Lite® Phosphatidylserine IgM ELISA INOVA DIAGNOSTICS, INC.
15 08426950593294 704635 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 IgA 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 APS U/mL. Ready to use.7. Phosphatidylserine 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 Phosphatidylserine IgA Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgA. Coloured green, 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. QUANTA Lite® Phosphatidylserine IgA ELISA INOVA DIAGNOSTICS, INC.
16 08426950593249 704625 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 IgG 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 GPS U/mL. Ready to use.7.Phosphatidylserine 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 Phosphatidylserine IgG Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgG. Coloured red, 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. QUANTA Lite® Phosphatidylserine IgG ELISA INOVA DIAGNOSTICS, INC.
17 08426950544210 701238 1. 1 QUANTA Flash aCL IgM Reagent Cartridge2. 1 QUANTA Flash aCL IgM Calibrator 1. 1 QUANTA Flash aCL IgM Reagent Cartridge2. 1 QUANTA Flash aCL IgM Calibrator 1 3. 1 QUANTA Flash aCL IgM Calibrator 2 QUANTA Flash® aCL IgM Reagents INOVA DIAGNOSTICS, INC.
18 08426950544203 701233 1. 1 QUANTA Flash aCL IgG Reagent Cartridge2. 1 QUANTA Flash aCL IgG Calibrator 1. 1 QUANTA Flash aCL IgG Reagent Cartridge2. 1 QUANTA Flash aCL IgG Calibrator 1 3. 1 QUANTA Flash aCL IgG Calibrator 2 QUANTA Flash® aCL IgG Reagents INOVA DIAGNOSTICS, INC.
19 08426950496960 0009802008 0009802008 HemosIL AcuStar Anti-Cardiolipin IgM HemosIL AcuStar Anti-Cardiolipin IgM INSTRUMENTATION LABORATORY COMPANY
20 08426950496953 0009802004 0009802004 HemosIL AcuStar Anti-Cardiolipin IgG HemosIL AcuStar Anti-Cardiolipin IgG INSTRUMENTATION LABORATORY COMPANY
21 08426950485988 708630 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 IgM III Control4. 1x 1.2mL prediluted ACA IgM III Calibrator A5. 1x 1.2mL prediluted ACA IgM III Calibrator B6. 1x 1.2mL prediluted ACA IgM III Calibrator C7. 1x 1.2mL prediluted ACA IgM III Calibrator D8. 1x 1.2mL prediluted ACA IgM III Calibrator E9. 1x 50mL ACA III Sample Diluent10. 1x 50mL ACA III PBS Concentrate, 20x concentrate11. 1x 10mL HRP IgM Conjugate, (goat), anti-human IgM12. 1x 10mL TMB Chromogen13. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid QUANTA Lite® ACA IgM III INOVA DIAGNOSTICS, INC.
22 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 QUANTA Lite® ACA IgG III INOVA DIAGNOSTICS, INC.
23 08426950454489 708620 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 III Decision Point4. 1x 1.2mL prediluted ACA III Screen Control5. 1x 50mL ACA III Sample Diluent6. 1x 50mL ACA III PBS Concentrate, 20x concentrate7. 1x 10mL HRP IgGAM Conjugate, (goat), anti-human IgGAM8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid QUANTA Lite® ACA Screen III INOVA DIAGNOSTICS, INC.
24 08426950448389 708635 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 IgA III Control4. 1x 1.2mL prediluted ACA IgA III Calibrator A5. 1x 1.2mL prediluted ACA IgA III Calibrator B6. 1x 1.2mL prediluted ACA IgA III Calibrator C7. 1x 1.2mL prediluted ACA IgA III Calibrator D8. 1x 1.2mL prediluted ACA IgA III Calibrator E9. 1x 50mL ACA III Sample Diluent10. 1x 50mL ACA III PBS Concentrate, 20x concentrate11. 1x 10mL HRP IgA Conjugate, (goat), anti-human IgA12. 1x 10mL TMB Chromogen13. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid QUANTA Lite® ACA IgA III INOVA DIAGNOSTICS, INC.
25 07340058410400 FCAR100T FCAR100T DIASTAT total anti-Cardiolipin EURO-DIAGNOSTICA AB
26 07340058410233 FCAR100M FCAR100M DIASTAT anti-Cardiolipin IgM EURO-DIAGNOSTICA AB
27 07340058410196 FCAR100G FCAR100G DIASTAT anti-Cardiolipin IgG EURO-DIAGNOSTICA AB
28 07333066014739 DECC055300 DECC055300 EliA Cardiolipin IgM Well EliA Cardiolipin IgM Well PHADIA AB
29 07333066014722 DECC055290 DECC055290 EliA Cardiolipin IgG Well EliA Cardiolipin IgG Well PHADIA AB
30 07333066014715 DECC055280 DECC055280 EliA Cardiolipin IgA Well EliA Cardiolipin IgA Well PHADIA AB
31 07333066013183 83-0009-01 83-0009-01 EliA APS Positive Control 2500/5000 EliA APS Positive Control 2500/5000 PHADIA AB
32 04260157080140 ORG515S ORG515S Anti-Cardiolipin Screen is an ELISA test system for the quantitative measurement Anti-Cardiolipin Screen is an ELISA test system for the quantitative measurement of IgG, IgM and IgA class autoantibodies against cardiolipin in human serum or plasma. This product is intended for professional in vitro diagnostic use only. ANTI-CARDIOLIPIN SCREEN ORGENTEC DIAGNOSTIKA GMBH
33 04260157080133 ORG515A ORG515A Anti-Cardiolipin Screen is an ELISA test system for the quantitative measurement Anti-Cardiolipin Screen is an ELISA test system for the quantitative measurement of IgA class autoantibodies against cardiolipin in human serum or plasma. This product is intended for professional in vitro diagnostic use only. ANTI-CARDIOLIPIN IgA ORGENTEC DIAGNOSTIKA GMBH
34 04260157080126 ORG515 ORG515 Anti-Cardiolipin IgG/IgM is an ELISA test system for the quantitative measuremen Anti-Cardiolipin IgG/IgM is an ELISA test system for the quantitative measurement of IgG and IgM class autoantibodies against cardiolipin in human serum or plasma. This product is intended for professional in vitro diagnostic use only. ANTI-CARDIOLIPIN IgG/IgM ORGENTEC DIAGNOSTIKA GMBH
35 04250289503068 7204US 7204US AESKULISA Cardiolipin-GM is a solid phase enzyme immunoassay employing highly pu AESKULISA Cardiolipin-GM is a solid phase enzyme immunoassay employing highly purified cardiolipin plus native human ß2-glycoprotein I for the quantitative and qualitative detection of IgG and /or IgM antibodies against cardiolipin in human serum. Anti-cardiolipin antibodies mainly recognize specific epitopes on a complex composed of cardiolipin and ß2glycoprotein I which are only expressed when ß2-glycoprotein I interacts with cardiolipin. The assay is an aid in the diagnosis and risk estimation of thrombosis in patients with systemic lupus erythematosus (SLE). AESKULISA® Cardiolipin-GM AESKU.DIAGNOSTICS GMBH & CO. KG
36 04250289503051 7203US 7203US AESKULISA Cardiolipin-A is a solid phase enzyme immunoassay employing highly pur AESKULISA Cardiolipin-A is a solid phase enzyme immunoassay employing highly purified cardiolipin plus native human ß2-glycoprotein I for the quantitative and qualitative detection of IgA antibodies against cardiolipin in human serum. Anti-cardiolipin antibodies mainly recognize specific epitopes on a complex composed out of cardiolipin and ß2-glycoprotein I which are expressed only when ß2-glycoprotein I interacts with cardiolipin. The assay is an aid in the diagnosis and risk estimation of thrombosis in patients with systemic lupus erythematosus (SLE). AESKULISA® Cardiolipin-A AESKU.DIAGNOSTICS GMBH & CO. KG
37 04250289503044 7202US 7202US AESKULISA Cardiolipin-Check is a solid phase enzyme immunoassay employing highly AESKULISA Cardiolipin-Check is a solid phase enzyme immunoassay employing highly purified cardiolipin plus native human ß2-glycoprotein I for the combined quantitative and qualitative detection of IgA, IgG and IgM antibodies against cardiolipin in human serum. Anticardiolipin antibodies mainly recognize specific epitopes on a complex composed out of cardiolipin and ß2-glycoprotein I which are expressed only when ß2-glycoprotein I interacts with cardiolipin. The assay is an aid in the diagnosis and risk estimation of thrombosis in patients with systemic lupus erythematosus (SLE). AESKULISA® Cardiolipin-Check AESKU.DIAGNOSTICS GMBH & CO. KG
38 04250289500845 3204 AESKULISA Cardiolipin-GM is a solid phase enzyme immunoassay employing highly pu AESKULISA Cardiolipin-GM is a solid phase enzyme immunoassay employing highly purified cardiolipin plus native human ß2-glycoprotein I for the quantitative and qualitative detection of IgG and /or IgM antibodies against cardiolipin in human serum. Anti-cardiolipin antibodies mainly recognize specific epitopes on a complex composed of cardiolipin and ß2glycoprotein I which are only expressed when ß2-glycoprotein I interacts with cardiolipin. The assay is an aid in the diagnosis and risk estimation of thrombosis in patients with systemic lupus erythematosus (SLE). AESKULISA® Cardiolipin-GM AESKU.DIAGNOSTICS GMBH & CO. KG
39 04250289500838 3203 AESKULISA Cardiolipin-A is a solid phase enzyme immunoassay employing highly pur AESKULISA Cardiolipin-A is a solid phase enzyme immunoassay employing highly purified cardiolipin plus native human ß2-glycoprotein I for the quantitative and qualitative detection of IgA antibodies against cardiolipin in human serum. Anti-cardiolipin antibodies mainly recognize specific epitopes on a complex composed out of cardiolipin and ß2-glycoprotein I which are expressed only when ß2-glycoprotein I interacts with cardiolipin. The assay is an aid in the diagnosis and risk estimation of thrombosis in patients with systemic lupus erythematosus (SLE). AESKULISA® Cardiolipin-A AESKU.DIAGNOSTICS GMBH & CO. KG
40 04250289500821 3202 AESKULISA Cardiolipin-Check is a solid phase enzyme immunoassay employing highly AESKULISA Cardiolipin-Check is a solid phase enzyme immunoassay employing highly purified cardiolipin plus native human ß2-glycoprotein I for the combined quantitative and qualitative detection of IgA, IgG and IgM antibodies against cardiolipin in human serum. Anticardiolipin antibodies mainly recognize specific epitopes on a complex composed out of cardiolipin and ß2-glycoprotein I which are expressed only when ß2-glycoprotein I interacts with cardiolipin. The assay is an aid in the diagnosis and risk estimation of thrombosis in patients with systemic lupus erythematosus (SLE). AESKULISA® Cardiolipin-Check AESKU.DIAGNOSTICS GMBH & CO. KG
41 04048474035896 EIA-3589 EIA-3589 Anti-Cardiolipin Screen ELISA is a test system for the quantitative measurement Anti-Cardiolipin Screen ELISA is a test system for the quantitative measurement of IgG, IgM and IgA class autoantibodies against cardiolipin in human serum or plasma. Anti-Cardiolipin Screen ELISA DRG INSTRUMENTS GESELLSCHAFT MIT BESCHRÄNKTER HAFTUNG
42 04048474035872 EIA-3587 EIA-3587 Anti-Cardiolipin IgG / IgM ELISA is a test system for the quantitative measureme Anti-Cardiolipin IgG / IgM ELISA is a test system for the quantitative measurement of IgG and IgM class autoantibodies against cardiolipin in human serum or plasma. Anti-Cardiolipin IgG/IgM ELISA DRG INSTRUMENTS GESELLSCHAFT MIT BESCHRÄNKTER HAFTUNG
43 00855360006113 13534 13534 INTENDED USE Detection and semi-quantitation of anti-phosphatidylserine antibodi INTENDED USE Detection and semi-quantitation of anti-phosphatidylserine antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use.SUMMARY AND EXPLANATION OF THE TEST High serum levels of anti-phospholipid antibodies are frequently detected in patients with autoimmune (i.e., SLE) and non-autoimmune diseases, as well as in apparently healthy individuals. These antibodies have been associated with an increased risk for recurrent arterial and venous thrombotic events, thrombocytopenia and fetal loss. Phosphatidylserine is a more physiologically relevant phospholipid due to its presence in cell membranes of endothelial cells and platelets.PRINCIPLE OF THE TESTThe test is an indirect ELISA. Diluted serum/plasma samples, calibrator sera, and controls are incubated in phosphatidylserine coated microwells. β2-glycoprotein I is provided in the sample diluent. 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 phosphatidylserine bound antibodies. Following another washing 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-phosphatidylserine (aPS) antibodies. Results are obtained by reading the Optical Density of each well in a spectrophotometer. Calibrator sera are provided with the IgG anti-phosphatidylserine antibody concentrations expressed in GPS (IgG aPS) units traceable to the reference preparations of the Louisville Antiphospholipid Laboratory Control and patient results are determined from the calibration curve. Refer to Package Insert. Corgenix Anti-Phosphatidylserine IgG Semi-Quantitative Test Kit (192 Well) CORGENIX MEDICAL CORPORATION
44 00855360006106 10206 10206 INTENDED USEDetection and semi-quantitation of IgA anti-phosphatidylserine (aPS) INTENDED USEDetection and semi-quantitation of IgA anti-phosphatidylserine (aPS) antibodies as an aid for assessingthe risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders(anti-phospholipid syndrome). For In Vitro Diagnostic Use.SUMMARY AND EXPLANATION OF THE TESTHigh 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. These antibodies have been associated with an increased risk for recurrent arterial and venous thrombotic events, thrombocytopenia, and fetal loss. Phosphatidylserine is a more physiologically relevant phospholipid due to its presence in cell membranes of endothelial cells and platelets.PRINCIPLE OF THE TESTThe test is an indirect ELISA. Diluted serum/citrated plasma samples, calibrator sera, and controls are incubated in phosphatidylserine coated microwells. β2-glycoprotein I is provided in the sample diluent. 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 phosphatidylserine bound antibodies. Following another washing 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 IgA Antiphosphatidylserine (aPS) antibodies. Results are obtained by reading the O.D. (optical density or absorbance) of each well in a spectrophotometer. IgA calibrator sera are provided, expressed as APS (IgA anti-phosphatidylserine) units. Control and patient results are determined from the calibration curve. Refer to Package Insert. REAADS Anti-Phosphatidylserine IgA Semi-Quantitative Test Kit (96 Well) CORGENIX MEDICAL CORPORATION
45 00855360006090 030-001 030-001 INTENDED USE Detection and semi-quantitation of anti-phosphatidylserine antibodi INTENDED USE Detection and semi-quantitation of anti-phosphatidylserine antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use.SUMMARY AND EXPLANATION OF THE ANTI-PHOSPHATIDYLSERINE TEST High serum levels of anti-phospholipid antibodies are frequently detected in patients with autoimmune (i.e., SLE) and non-autoimmune diseases, as well as in apparently healthy individuals. These antibodies have been associated with an increased risk for recurrent arterial and venous thrombotic events, thrombocytopenia and fetal loss. Phosphatidylserine is a more physiologically relevant phospholipid due to its presence in cell membranes of endothelial cells and platelets.PRINCIPLE OF THE TEST The test is an indirect ELISA. Diluted serum/plasma samples, calibrator sera, and controls are incubated in phosphatidylserine coated microwells. β2-glycoprotein I is provided in the sample diluent. After the removal of unbound serum/plasma proteins by washing, antibodies specific for human IgG or IgM, labeled with horseradish peroxidase (HRP), are added forming complexes with the phosphatidylserine bound antibodies. Two enzyme-conjugated antibody solutions are provided, one specific for human IgG antibodies and one specific for human IgM antibodies. Following another washing 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-phosphatidylserine (aPS) antibodies. Results are obtained by reading the O.D. of each well in a spectrophotometer. Calibrator sera are provided for both IgG and IgM antibody concentrations expressed in GPS or MPS units. Control and patient results are determined from the calibration curve. Refer to Package Insert. REAADS Anti-Phosphatidylserine IgG/IgM Semi-Quantitative Test Kit (96 Well) CORGENIX MEDICAL CORPORATION
46 00855360006083 13530 13530 INTENDED USE For the detection and semi-quantitation of anti-cardiolipin antibod INTENDED USE For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use.SUMMARY AND EXPLANATION OF THE TEST Anti-phospholipid antibodies are autoantibodies that react with most negatively charged phospholipids, including cardiolipin (CL). Anti-cardiolipin (aCL) antibodies are frequently found in patients with systemic lupus erythematosus (SLE). Elevated levels of aCL antibodies have been reported to be significantly associated with the presence of both venous and arterial thrombosis, thrombocytopenia, and recurrent fetal loss. The term “anti-phospholipid syndrome” (APS) has been introduced to describe patients who present these clinical manifestations. PRINCIPLE OF THE TEST The test is an indirect ELISA. Diluted serum samples, calibrator sera, and controls are incubated in cardiolipin coated microwells, allowing aCL antibodies present in the samples to react with the immobilized antigen. After the removal of unbound serum proteins by washing, antibodies specific for human IgA labeled with horseradish peroxidase (HRP) are added forming complexes with the cardiolipin bound antibodies. Following another wash step, 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 IgA aCL antibodies. Results are obtained by reading the O.D. of each well with a spectrophotometer. Calibrator sera are provided, with the IgA aCL concentration expressed in APL units. Control and patient results are determined from the calibration curve. Refer to Package Insert. Corgenix Anti-Cardiolipin IgA Semi-Quantitative Test Kit (192 Well) CORGENIX MEDICAL CORPORATION
47 00855360006076 13529 13529 INTENDED USE For the detection and semi-quantitation of anti-cardiolipin antibod INTENDED USE For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use.SUMMARY AND EXPLANATION OF THE TEST Anti-phospholipid antibodies are autoantibodies that react with most negatively charged phospholipids, including cardiolipin (CL). Anti-cardiolipin (aCL) antibodies are frequently found in patients with systemic lupus erythematosus (SLE). Elevated levels of aCL antibodies have been reported to be significantly associated with the presence of both venous and arterial thrombosis, thrombocytopenia, and recurrent fetal loss. The term “anti-phospholipid syndrome” (APS) has been introduced to describe patients who present these clinical manifestations. PRINCIPLE OF THE TEST The test is an indirect ELISA. Diluted serum samples, calibrator sera, and controls are incubated in cardiolipin coated microwells, allowing aCL antibodies present in the samples to react with the immobilized antigen. After removal of unbound serum proteins by washing, antibodies specific for human IgM labeled with horseradish peroxidase (HRP) are added forming complexes with the cardiolipin bound antibodies. Following another wash step, 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 aCL antibodies. Results are obtained by reading the O.D. of each well with a spectrophotometer. Calibrator sera are provided, with the IgM aCL concentrations expressed in MPL units. One MPL unit is equivalent to 1 μg/mL of an affinity purified standard IgM sample. Control and patient results are determined from the calibration curve. Refer to Package Insert. Corgenix Anti-Cardiolipin IgM Semi-Quantitative Test Kit (192 Well) CORGENIX MEDICAL CORPORATION
48 00855360006069 13525 13525 INTENDED USE For the detection and semi-quantitation of anti-cardiolipin antibod INTENDED USE For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use.SUMMARY AND EXPLANATION OF THE TEST Anti-phospholipid antibodies are auto antibodies that react with most negatively charged phospholipids, including cardiolipin (CL). Anti-cardiolipin (aCL) antibodies are frequently found in patients with systemic lupus erythematosus (SLE). Elevated levels of aCL antibodies have been reported to be significantly associated with the presence of both venous and arterial thrombosis, thrombocytopenia, and recurrent fetal loss. The term “anti-phospholipid syndrome” (APS) has been introduced to describe patients who present these clinical manifestations.PRINCIPLE OF THE TEST The test is an indirect ELISA. Diluted serum samples, calibrator sera, and controls are incubated in cardiolipin coated microwells, allowing aCL antibodies present in the samples to react with the immobilized antigen. After removal of unbound serum proteins by washing, antibodies specific for human IgG labeled with horseradish peroxidase (HRP) are added forming complexes with the cardiolipin bound antibodies. Following another wash step, 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 aCL antibodies. Results are obtained by reading the O.D. of each well with a spectrophotometer. Calibrator sera are provided, with the IgG aCL concentrations expressed in GPL units. One GPL unit is equivalent to 1 μg/mL of an affinity purified standard IgG sample. Control and patient results are determined from the calibration curve. Refer to Package Insert. Corgenix Anti-Cardiolipin IgG Semi-Quantitative Test Kit (192 Well) CORGENIX MEDICAL CORPORATION
49 00855360006052 026-001 026-001 INTENDED USE For the detection and semi-quantitation of anti-cardiolipin antibod INTENDED USE For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use.SUMMARY AND EXPLANATION OF THE IGA TEST Anti-phospholipid antibodies are autoantibodies that react with most negatively charged phospholipids, including cardiolipin (CL). Anti-cardiolipin (aCL) antibodies are frequently found in patients with systemic lupus erythematosus (SLE). Elevated levels of aCL antibodies have been reported to be significantly associated with the presence of both venous and arterial thrombosis, thrombocytopenia, and recurrent fetal loss. The term “anti-phospholipid syndrome” (APS) has been introduced to describe patients who present these clinical manifestations. PRINCIPLE OF THE TEST The test is an indirect ELISA. Diluted serum samples, calibrator sera, and controls are incubated in cardiolipin coated microwells, allowing aCL antibodies present in the samples to react with the immobilized antigen. After removal of unbound serum proteins by washing, antibodies specific for human IgA labeled with horseradish peroxidase (HRP) are added forming complexes with the cardiolipin bound antibodies. Following another wash step, 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 IgA aCL antibodies. Results are obtained by reading the O.D. of each well with a spectrophotometer. Calibrator sera are provided, with the IgA aCL concentration expressed in APL units. The O.D. values of the controls and patient samples are multiplied by the conversion factor to obtain IgA aCL values, expressed in APL units. Control and patient results are determined from the calibration curve. Refer to Package Insert. REAADS IgA Anti-Cardiolipin Semi-Quantitative Test Kit (96-Well) CORGENIX MEDICAL CORPORATION
50 00850487007517 Cardiolipin G Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA) SeraQuest QUEST INTERNATIONAL, INC.