No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 04049016045403 | FA 1522-2010 | DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | ANA IFA: HEp-20-10 | ||
2 | 04049016045397 | FA 1522-2005 | ANA IFA: HEp-20-10 | |||||
3 | 04049016045380 | FA 1522-2003 | DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | ANA IFA: HEp-20-10 | ||
4 | 04049016145745 | MP 2606-0200 | QJR | Reagents, 2019-Novel Coronavirus Nucleic Acid | EURORealTime SARS-CoV-2 | |||
5 | 04049016145691 | MP 2606-0100 | QJR | Reagents, 2019-Novel Coronavirus Nucleic Acid | EURORealTime SARS-CoV-2 | |||
6 | 04049016145660 | MP 2606-0425 | QJR | Reagents, 2019-Novel Coronavirus Nucleic Acid | EURORealTime SARS-CoV-2 | |||
7 | 04049016145653 | MP 2606-0225 | QJR | Reagents, 2019-Novel Coronavirus Nucleic Acid | EURORealTime SARS-CoV-2 | |||
8 | 04049016145646 | MP 2606-0125 | QJR | Reagents, 2019-Novel Coronavirus Nucleic Acid | EURORealTime SARS-CoV-2 | |||
9 | 04049016114895 | EI 2132-9601-24 O | LSR | Reagent, Borrelia Serological Reagent | 2 | Lyme ELISA (IgG/IgM) | ||
10 | 04049016109723 | YG 0153-0101 | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | EUROBlotOne | ||
11 | 04049016109709 | YG 0033-0101-5 | JQW | Station, Pipetting And Diluting, For Clinical Use | 1 | Sprinter XL (model 160 samples, IFA) | ||
12 | 04049016109693 | YG 0033-0101-4 | JQW | Station, Pipetting And Diluting, For Clinical Use | 1 | Sprinter XL (model 160 samples, IFA incl. incubator) | ||
13 | 04049016109679 | YG 0033-0101-26 | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | Sprinter XL (model 240 samples, IFA/ELISA) | ||
14 | 04049016096047 | EI 2050-9601 M | GOX | Antigen, B. Pertussis | 1 | Anti-Bordetella pertussis ELISA (IgM) | ||
15 | 04049016092575 | FA 112d-2010-51 | OSK | Anti-Glutamate Receptor (Type Nmda) Ifa | 2 | Anti-Glutamate receptor (type NMDA) IFA | ||
16 | 04049016092568 | FA 112d-2005-51 | OSK | Anti-Glutamate Receptor (Type Nmda) Ifa | 2 | Anti-Glutamate receptor (type NMDA) IFA | ||
17 | 04049016092551 | FA 112d-1010-51 | OSK | Anti-Glutamate Receptor (Type Nmda) Ifa | 2 | Anti-Glutamate receptor (type NMDA) IFA | ||
18 | 04049016092544 | FA 112d-1005-51 | OSK | Anti-Glutamate Receptor (Type Nmda) Ifa | 2 | Anti-Glutamate receptor (type NMDA) IFA | ||
19 | 04049016092537 | FA 112d-1003-51 | OSK | Anti-Glutamate Receptor (Type Nmda) Ifa | 2 | Anti-Glutamate receptor (type NMDA) IFA | ||
20 | 04049016091608 | EA 1502-4801-1 G | OEG | Autoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 230 | 2 | Anti-BP230-CF ELISA (IgG) | ||
21 | 04049016091288 | FA 1201-2010-32 | MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 | EUROPLUS Granulocyte Mosaic 32 | ||
22 | 04049016091271 | FA 1201-2005-32 | MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 | EUROPLUS Granulocyte Mosaic 32 | ||
23 | 04049016091264 | FA 1201-1010-32 | MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 | EUROPLUS Granulocyte Mosaic 32 | ||
24 | 04049016091257 | FA 1201-1005-32 | MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 | EUROPLUS Granulocyte Mosaic 32 | ||
25 | 04049016091240 | FA 1201-1003-32 | MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 | EUROPLUS Granulocyte Mosaic 32 | ||
26 | 04049016089193 | EA 1496-4801 G | NBO | Autoantibodies,Skin(Desmoglein 1 And Desmoglein 3) | 2 | Anti-Desmoglein 3 ELISA (IgG) | ||
27 | 04049016089186 | EA 1495-4801 G | NBO | Autoantibodies,Skin(Desmoglein 1 And Desmoglein 3) | 2 | Anti-Desmoglein 1 ELISA (IgG) | ||
28 | 04049016086017 | EA 1590-9601-9 G | LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | Anti-ENA Pool ELISA (IgG) | ||
29 | 04049016085478 | DN 2050-24001 G | GOX | Antigen, B. Pertussis | 1 | EUROLINE Bordetella pertussis (IgG) | ||
30 | 04049016085447 | DN 2050-1601 G | GOX | Antigen, B. Pertussis | 1 | EUROLINE Bordetella pertussis (IgG) | ||
31 | 04049016068822 | YG 0151-0101 | JQW | Station, Pipetting And Diluting, For Clinical Use | 1 | EUROBlotMaster | ||
32 | 04049016067887 | FI 2861-2005 M | LSG | Candida Species, Antibody Detection | 2 | Anti-Candida albicans IFA (IgM) | ||
33 | 04049016067870 | FI 2861-1010 M | LSG | Candida Species, Antibody Detection | 2 | Anti-Candida albicans IFA (IgM) | ||
34 | 04049016067863 | FI 2861-1005 M | LSG | Candida Species, Antibody Detection | 2 | Anti-Candida albicans IFA (IgM) | ||
35 | 04049016067856 | FI 2861-1003 M | LSG | Candida Species, Antibody Detection | 2 | Anti-Candida albicans IFA (IgM) | ||
36 | 04049016045366 | FA 1522-1050 | DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | ANA IFA: HEp-20-10 | ||
37 | 04049016045359 | FA 1522-1010 | DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | ANA IFA: HEp-20-10 | ||
38 | 04049016045342 | FA 1522-1005 | DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | ANA IFA: HEp-20-10 | ||
39 | 04049016045335 | FA 1522-1003 | DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | ANA IFA: HEp-20-10 | ||
40 | 04049016035930 | EV 3011-9601 A | MST | Antibodies, Gliadin | 2 | Anti-Gliadin (GAF-3X) ELISA (IgA) | ||
41 | 04049016028369 | EI 2721-9601-1 A | GQT | Antisera, Cf, Parainfluenza Virus 1-4 | 1 | Anti-Parainfluenza Viruses Pool ELISA (IgA) | ||
42 | 04049016028321 | EI 2691-9601-1 G | GNS | Antisera, Hai, Influenza Virus A, B, C | 1 | Anti-Influenza A/B Virus Pool ELISA (IgG) | ||
43 | 04049016027560 | EI 2189-9601 G | GSM | Antisera, Fluorescent, Brucella Spp. | 2 | Anti-Brucella abortus ELISA (IgG) | ||
44 | 04049016027522 | EI 2150-9601 M | MJH | Legionella, Spp., Elisa | 2 | Anti-Legionella pneumophila ELISA (IgM) | ||
45 | 04049016134992 | DY 2133-24001-1 M | LSR | Reagent, Borrelia Serological Reagent | 2 | Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) | ||
46 | 04049016134985 | DY 2133-3001-1 M | LSR | Reagent, Borrelia Serological Reagent | 2 | Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) | ||
47 | 04049016119999 | FC 1911-0010 A | MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | 2 | IFA: Oesophagus (Monkey) IgA EUROPattern | ||
48 | 04049016119982 | FC 1911-2010 A | MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | IFA: Oesophagus (Monkey) IgA EUROPattern | |||
49 | 04049016119975 | FC 1911-2005 A | MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | 2 | IFA: Oesophagus (Monkey) IgA EUROPattern | ||
50 | 04049016119968 | FC 1911-1010 A | MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | 2 | IFA: Oesophagus (Monkey) IgA EUROPattern |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00817273020266 | 720-450 | "720-450 anti-TPO IgG Test Kit" | Diamedix | DIAMEDIX CORPORATION | |
2 | 00817273020259 | 720-440 | "720-440 anti-PR-3 (C-ANCA) IgG Test Kit" | Diamedix | DIAMEDIX CORPORATION | |
3 | 00816879020137 | FGA13 | 96 well ELISA for the detection of anti-GBM antibodies in human serum | Autostat II Anti-GBM | HYCOR BIOMEDICAL LLC | |
4 | 00816879020120 | FGA12 | 96 well ELISA for the detection of anti-MPO antibodies in human serum | Autostat II Anti-MPO | HYCOR BIOMEDICAL LLC | |
5 | 00816879020113 | FGA11 | 96 well ELISA for the detection of anti-PR 3 antibodies in human serum | Autostat II Anti-PR 3 | HYCOR BIOMEDICAL LLC | |
6 | 00813545023614 | A120L | A120L | C-ANCA 120 Test(L) | SCIMEDX CORPORATION | |
7 | 00813545023607 | A060PL | A060PL | P-ANCA 60 Test(L) | SCIMEDX CORPORATION | |
8 | 00813545023591 | A060L | A060L | C-ANCA 60 Test(L) | SCIMEDX CORPORATION | |
9 | 00813545023584 | A006P | A006P | P-ANCA 6 Well Slide | SCIMEDX CORPORATION | |
10 | 00813545023577 | A006 | A006 | ANCA 6 Well Slide | SCIMEDX CORPORATION | |
11 | 00813545022945 | 5696L | 5696L | GBM P KDY Test(L) 96 | SCIMEDX CORPORATION | |
12 | 00813545022938 | 5648L | 5648L | GBM P KDY Test(L) 48 | SCIMEDX CORPORATION | |
13 | 00813545020606 | 5608 | 5608 | P KDY Pack 8 WELL | SCIMEDX CORPORATION | |
14 | 00813545020583 | 5601 | 5601 | P KDY Pack 4 WELL | SCIMEDX CORPORATION | |
15 | 42601861205090 | AUTOMATED IFA SYSTEM | IOS-1000 | Automated system for immunofluorescence processing with an integrated fluorescen Automated system for immunofluorescence processing with an integrated fluorescence microscope and software for routine laboratory use by professional users under controlled environmental conditions. | HELIOS | AESKU.SYSTEMS GMBH & CO. KG |
16 | M74900IN2201 | IN220 | IN220 | Automated microscope system for immunofluorescent determination of autoantibodies. | Image Navigator® | IMMUNO CONCEPTS INC |
17 | M74900IN1101 | IN110 | IN110 | Automated microscope system for immunofluorescent determination of autoantibodies. | Image Navigator® | IMMUNO CONCEPTS INC |
18 | 08426951056538 | 708215 | 1. 20 x 12-well bar-coded dsDNA (Crithidia luciliae) Slide2. 1 x 15mL FITC Anti- 1. 20 x 12-well bar-coded dsDNA (Crithidia luciliae) Slide2. 1 x 15mL FITC Anti-Human IgG Conjugate with DAPI3. 1 x 0.5mL dsDNA Positive4. 1 x 0.5mL IFA System Negative Control5. 2 x 25mL PBS II Concentrate (40x)6. 1 x 7mL Mounting Medium7. 1 x 20 Coverslips | NOVA Lite® DAPI dsDNA Crithidia Luciliae Kit | INOVA DIAGNOSTICS, INC. | |
19 | 08426950767053 | 704338 | 1. 1 x 7mL Mounting Medium2. 1 x 15mL FITC IgG Conjugate with DAPI3. 1 x Coversl 1. 1 x 7mL Mounting Medium2. 1 x 15mL FITC IgG Conjugate with DAPI3. 1 x Coverslips (20 ea)4. 1 x 0.5mL IFA System Negative Control5. 1 x 0.5mL cANCA Positive6. 1 x 0.5mL pANCA Positive7. 20 x ANCA (Ethanol Fixed Human Neutrophil) Slide (12 well)8. 2 x 25mL PBS II Concentrate (40x) | NOVA Lite® DAPI ANCA (Ethanol) Kit | INOVA DIAGNOSTICS, INC. | |
20 | 08426950767046 | 704337 | 1. 1 x 7mL Mounting Medium2. 1 x 15mL FITC IgG Conjugate with DAPI3. 1 x Coversl 1. 1 x 7mL Mounting Medium2. 1 x 15mL FITC IgG Conjugate with DAPI3. 1 x Coverslips (20 ea)4. 1 x 0.5mL IFA System Negative Control5. 1 x 0.5mL cANCA Positive6. 1 x 0.5mL pANCA Positive7. 20 x ANCA (Formalin Fixed Human Neutrophil) Slide (12 well)8. 2 x 25mL PBS II Concentrate (40x) | NOVA Lite® DAPI ANCA (Formalin) Kit | INOVA DIAGNOSTICS, INC. | |
21 | 08426950643708 | ALDR1000 | The NOVA View AUTOLoader is an optional hardware accessory that performs the aut The NOVA View AUTOLoader is an optional hardware accessory that performs the automated transfer of slide carriers to and from NOVA View, thereby providing a continuous load capability without human interaction. | NOVA View® AUTOLoader | INOVA DIAGNOSTICS, INC. | |
22 | 08426950621843 | 704320 | 1. 20x ANA Hep- 2 -QR Slide (12 well)2. 1x 0.5mL IFA System Negative Control3. 1 1. 20x ANA Hep- 2 -QR Slide (12 well)2. 1x 0.5mL IFA System Negative Control3. 1x 15mL FITC IgG Conjugate with DAPI 4. 1x 7mL Mounting Medium5. 2x 25mL PBS II Concentrate (40x)6 .1x Coverlips, 20 each7. 1x 0.5mL ANA Titratable Pattern | NOVA Lite® DAPI ANA Kit | INOVA DIAGNOSTICS, INC. | |
23 | 08426950621614 | NV2000 | NOVA View® Automated Fluorescent Microscope is an automated system consisting of NOVA View® Automated Fluorescent Microscope is an automated system consisting of a fluorescence microscope and software that acquires, analyzes, stores and displays digital images of stained indirect immunofluorescent slides. Optional AutoLoader available as an accessory. | NOVA View® | INOVA DIAGNOSTICS, INC. | |
24 | 08426950602125 | 708301 | 1. 20x ANCA (Ethanol Fixed Human Neutrophil), slides - 12 wells2. 1x 15mL FITC I 1. 20x ANCA (Ethanol 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. 2x 25mL PBS II Concentrate (40x)7. 1x 7mL Mounting Medium8. 1x 20 Coverslips9. 1x Direction Insert | NOVA Lite® ANCA (Ethanol) Kit with DAPI | INOVA DIAGNOSTICS, INC. | |
25 | 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" | NOVA Lite® ANCA (Formalin) Kit with DAPI | INOVA DIAGNOSTICS, INC. | |
26 | 08426950595823 | 708740.10 | 1. 10x GBM ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL predi 1. 10x GBM ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted GBM ELISA Low Positive4. 5x 1.2mL prediluted GBM ELISA High Positive5. 9x 50mL HRP Sample Diluent6. 10x 25mL HRP Wash Concentrate, 40x concentrate7. 10x 10mL HS HRP IgG Conjugate, (goat), anti-human IgG8. 10x 10mL TMB Chromogen9. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid Additional Materials Required But Not Provided | QUANTA Lite® GBM ELISA Bulk Pack | INOVA DIAGNOSTICS, INC. | |
27 | 08426950594550 | 704660.10 | 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. PR3 SC Coated Wells: 10 plates containing 12 breakapart 8 well strips coated with PR3 antigen, colour coded red. 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. PR3 SC ELISA Calibrators: 25 bottles (5 bottles each) containing 1.2mL of diluted human serum, with the following concentrations of anti-PR3 autoantibody: 100, 33.3, 11.1, 3.7, 1.23 U/mL. Ready to use.7. PR3 SC Positive Control: 5 bottles containing 1.2mL of diluted human serum. Ready to use.8.ELISA Negative Control: 5 bottles containing 1.2mL of diluted human serum. Ready to use.9. HRP PR3 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. | QUANTA Lite® PR3 SC ELISA Bulk Pack | INOVA DIAGNOSTICS, INC. | |
28 | 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. | QUANTA Lite® MPO SC ELISA Bulk Pack | INOVA DIAGNOSTICS, INC. | |
29 | 08426950594109 | 708297 | 1. 20x12-well ANCA Neutrophil substrate slides (formalin-fixed)2. 1x 1mL pANCA P 1. 20x12-well ANCA Neutrophil substrate slides (formalin-fixed)2. 1x 1mL pANCA Positive Control (prediluted) 3. 1x 1mL cANCA Positive Control (prediluted) 4. 1x 1mL ANA Positive Control (prediluted) 5. 1x 1mL IFA System Negative Control6. 1x 15mL anti Human IgG AFF Fluorescein with Evans Blue7. 2x 25mL PBS II Concentrate (40x)8. 1x 3mL 1% Evans Blue 9. 1x 10mL Mounting Medium10. 1x 20 Coverslips11. 1x Instruction leaflet | NOVA Lite® ANCA Formalin Kit | INOVA DIAGNOSTICS, INC. | |
30 | 08426950594055 | 708299 | 1. 10x 6-well ANCA ethanol-fixed human neutrophil substrate slides2. 1x 4mL FITC 1. 10x 6-well ANCA ethanol-fixed human neutrophil substrate slides2. 1x 4mL FITC Anti Human IgG Conjugate 3. 1x 0.5 mL cANCA Positive4. 1x 0.5 mL pANCA Positive 5. 1x 0.5mL IFA System Negative Control6. 1x 25mL PBS II Concentrate (40x)7. 1x 7mL Mounting Medium8. 1x 10 Coverslips | NOVA Lite® ANCA Kit | INOVA DIAGNOSTICS, INC. | |
31 | 08426950584650 | 701143 | 1. 1 QUANTA Flash GBM Reagent Cartridge | QUANTA Flash® GBM Reagents | INOVA DIAGNOSTICS, INC. | |
32 | 08426950554103 | 708295 | 1. 10x 6-well ANCA Neutrophil substrate slides (formalin-fixed)2. 1x 1mL pANCA P 1. 10x 6-well ANCA Neutrophil substrate slides (formalin-fixed)2. 1x 1mL pANCA Positive Control (prediluted) 3. 1x 1mL ANA Positive Control (prediluted) 4. 1x 1mL IFA System Negative Control5. 1x7mL anti Human IgG AFF Fluorescein with Evans Blue6. 2x 25mL PBS II Concentrate (40x) 7. 1x 3mL 1% Evans Blue Counterstain8. 1x 3mL Mounting Medium9. 1x 10 Coverslips10. 1x Instruction leaflet | NOVA Lite® ANCA Formalin Kit | INOVA DIAGNOSTICS, INC. | |
33 | 08426950544258 | 701138 | 1. 1 QUANTA Flash PR3 Reagent Cartridge | QUANTA Flash® PR3 Reagents | INOVA DIAGNOSTICS, INC. | |
34 | 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 | QUANTA Lite® PR3 SC ELISA | INOVA DIAGNOSTICS, INC. | |
35 | 08426950544197 | 701133 | 1. 1 QUANTA Flash MPO Reagent Cartridge | QUANTA Flash® MPO Reagents | INOVA DIAGNOSTICS, INC. | |
36 | 08426950544180 | 704655 | 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: 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: 2 bottles containing 50mL of buffer for sample dilution. Coloured yellow, ready to use.5. HRP Wash Concentrate: 1 bottle containing 25mL of a 40-fold concentrated buffer for washing the wells. 6. MPO SC ELISA Calibrators: 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: 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 MPO SC IgG Conjugate: 1 bottle containing 10mL of purified peroxidase labelled antibody to human IgG. 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® MPO SC ELISA | INOVA DIAGNOSTICS, INC. | |
37 | 08426950513995 | 708296 | 1. 20x 12-well ANCA ethanol-fixed human neutrophil substrate slides2. 1x 15mL FI 1. 20x 12-well ANCA ethanol-fixed human neutrophil substrate slides2. 1x 15mL FITC Anti Human IgG Conjugate 3. 1x 0.5 mL cANCA Positive4. 1x 0.5 mL pANCA Positive 5. 1x 0.5mL IFA System Negative Control6. 2x 25mL PBS II Concentrate (40x)7. 1x 7mL Mounting Medium8. 1x 20 Coverslips | NOVA Lite® ANCA Kit | INOVA DIAGNOSTICS, INC. | |
38 | 08426950512912 | 708298 | 1. 20x 12-well ANCA ethanol-fixed human neutrophil substrate slides2. 1x 15mL FI 1. 20x 12-well ANCA ethanol-fixed human neutrophil substrate slides2. 1x 15mL FITC Anti Human IgG Conjugate 3. 1x 0.5 mL cANCA Positive4. 1x 0.5 mL pANCA Positive 5. 1x 0.5mL IFA System Negative Control6. 2x 25mL PBS II Concentrate (40x)7. 1x 7mL Mounting Medium8. 1x 20 Coverslips | NOVA Lite® ANCA Kit | INOVA DIAGNOSTICS, INC. | |
39 | 08426950456216 | 708290 | 1. 10x 6-well ANCA ethanol-fixed human neutrophil substrate slides2. 1x 4mL FITC 1. 10x 6-well ANCA ethanol-fixed human neutrophil substrate slides2. 1x 4mL FITC Anti Human IgG Conjugate 3. 1x 0.5 mL cANCA Positive4. 1x 0.5 mL pANCA Positive 5. 1x 0.5mL IFA System Negative Control6. 1x 25mL PBS II Concentrate (40x)7. 1x 7mL Mounting Medium8. 1x 10 Coverslips | NOVA Lite® ANCA Kit | INOVA DIAGNOSTICS, INC. | |
40 | 08426950454533 | 708740 | 1. 1x GBM ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL predil 1. 1x GBM ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted GBM ELISA Low Positive4. 1x 1.2mL prediluted GBM ELISA High Positive5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HS HRP IgG Conjugate, (goat), anti-human IgG8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® GBM ELISA | INOVA DIAGNOSTICS, INC. | |
41 | 08426950448303 | 708705 | 1. 1x PR-3 IgG ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL pr 1. 1x PR-3 IgG ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted PR-3 IgG ELISA Low Positive4. 1x 1.2mL prediluted PR-3 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 | QUANTA Lite® PR-3 IgG ELISA | INOVA DIAGNOSTICS, INC. | |
42 | 08426950448280 | 708700 | 1. 1x MPO IgG ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL pre 1. 1x MPO IgG ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted MPO IgG ELISA Low Positive4. 1x 1.2mL prediluted MPO 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 | QUANTA Lite® MPO IgG ELISA | INOVA DIAGNOSTICS, INC. | |
43 | 08059304340109 | Zeus dIFine | Zeus dIFine | VISIA LAB SRL | ||
44 | 07350008750098 | Precision i5 | Stationary x-ray system intended for obtaining radiographic images portions of t Stationary x-ray system intended for obtaining radiographic images portions of the human body in a clinical environment. The device is not intended for mammography. | OMNERA 500A | ARCOMA AB | |
45 | 07340058410943 | CapMPO US | CapMPO US | WIESLAB Capture MPO-ANCA | EURO-DIAGNOSTICA AB | |
46 | 07340058410936 | CapPR3 US | CapPR3 US | WIESLAB Capture PR3 ANCA | EURO-DIAGNOSTICA AB | |
47 | 07340058410707 | GCP100 | GCP100 | WIESLAB antiGBM, ANCA Screen kit | EURO-DIAGNOSTICA AB | |
48 | 07340058410639 | CP111 | CP111 | WIESLAB ANCA Screen kit | EURO-DIAGNOSTICA AB | |
49 | 07333066014784 | DECC055370 | DECC055370 | EliA MPOS Well | EliA MPOS Well | PHADIA AB |
50 | 07333066014777 | DECC055360 | DECC055360 | EliA PR3S Well | EliA PR3S Well | PHADIA AB |