No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00816057021192 | NC-909001 | NC-909001 | Detection of Syphilis | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI Disposible Stirrer Pipet |
2 | 00816057021185 | NC-5071-002-500 | NC-5071-002-500 | Disposable Pipet, 500/bag | GTO | Anti-Streptokinase | 1 | ASI Disposible Stirrer Pipet |
3 | 00816057021123 | NC-987X30LCA | NC-987X30LCA | Detection of Syphilis, 30 Well, Cutsom | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
4 | 00816057021116 | NC-987X30 | NC-987X30 | Detection of Syphilis, 30 Well | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
5 | 00816057021109 | NC-987X15 | NC-987X15 | Detection of Syphilis, 15 well | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
6 | 00816057021093 | NC-987X10E | NC-987X10E | Detection of Syphilis, 10 well, Export | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
7 | 00816057021086 | NC-987530LCA | NC-987530LCA | Detection of Syphilis, 30 well, custom | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
8 | 00816057021079 | NC-987530E | NC-987530E | Detection of Syphilis, 30 well, Export | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
9 | 00816057021062 | NC-987530 | NC-987530 | Detection of Syphilis, 30 well | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
10 | 00816057021055 | NC-987515 | NC-987515 | Detection of Syphilis, 15 well | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
11 | 00816057021048 | NC-987510LCA | NC-987510LCA | Detection of Syphilis, no controls, 10 well, custom | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
12 | 00816057021031 | NC-987510 | NC-987510 | Detection of Syphilis, no controls, 10 well | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
13 | 00816057021017 | NC-987110LCA | NC-987110LCA | Detection of Syphilis, no controls, custom | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
14 | 00816057021000 | NC-987110 | NC-987110 | Detection of Syphilis, no controls | ASI RPR Card Test for Syphilis | |||
15 | 00816057020881 | NC-90010000-30 | NC-90010000-30 | Detection of Syphilis, 30 well | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
16 | 00816057020874 | NC-90010000-10 | NC-90010000-10 | Detection of Syphilis, 10 well | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
17 | 00816057020867 | NC-9005000-30T | NC-9005000-30T | Detection of Syphilis, 30 Well, TDH | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
18 | 00816057020850 | NC-9005000-30E | NC-9005000-30E | Detection of Syphilis, Export, 30 Well | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
19 | 00816057020843 | NC-9005000-30 | NC-9005000-30 | Detection of Syphilis, 30 well | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
20 | 00816057020836 | NC-9005000-10T | NC-9005000-10T | Detection of Syphilis, 10 well, TDH | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
21 | 00816057020812 | NC-9005000-10 | NC-9005000-10 | Detection of Syphilis, 10 well | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
22 | 00816057020805 | NC-900500T | NC-900500T | Detection of Syphilis, TDH | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
23 | 00816057020799 | NC-900500E | NC-900500E | Detection of Syphilis, Export | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
24 | 00816057020782 | NC-900500-NYE | NC-900500-NYE | Detection of Syphilis, Export, 3x3ml | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
25 | 00816057020775 | NC-900500-NEO | NC-900500-NEO | Detection for Syphilis, Export, No Controls | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
26 | 00816057020768 | NC-900500-FD | NC-900500-FD | Detection of Syphilis, Export (French) | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
27 | 00816057020751 | NC-900500 | NC-900500 | Syphilis screening test - Nontreponemal | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
28 | 00816057020744 | NC-900100E | NC-900100E | Detection of Syphilis, Export | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
29 | 00816057020720 | NC-900100-FD | NC900100-FD | Detection of Syphilis, Export (French) | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
30 | 00816057020713 | NC-900100 | NC-900100 | Detection of Syphilis | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
31 | 00816057020706 | NC-900025E | NC-900025E | Syphilis Screening Test, Export | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
32 | 00816057020690 | NC-900025 | NC-900025 | Syphilis Screening Test | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
33 | 00816057020614 | NC-860096-AG | NC-860096-AG | Detection of Mumps antibody | LJY | Enzyme Linked Immunoabsorbent Assay, Mumps Virus | 1 | ASI Mumps IgG EIA Test |
34 | 00816057020577 | NC-830096-AG | NC-830096-AG | Detection of Herpes Simplex 1 and 2 Antibodies | LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | 2 | ASI HSV IgG EIA Test |
35 | 00816057021642 | NC-705001 | NC705001 | Detection of Rheumatoid Factor | DHR | System, Test, Rheumatoid Factor | 2 | ASI RF Direct Slide Test Control Set |
36 | 00816057021628 | NC-505001 | NC-505001 | Detection of C-Reactive Protein | DCN | System, Test, C-Reactive Protein | 2 | ASI CRP Control Set |
37 | 00816057021253 | NC-909002 | NC-909002 | Detection of Syphilis | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Dispensing Bottle |
38 | 00816057021246 | NC-90900210 | NC-90900210 | Detection of Syphilis | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Dispensing Bottle |
39 | 00816057021239 | NC-5072-002 | NC-5072-002 | Blunt, 20 gauge needle cover | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Dropper Needle Cover |
40 | 00816057020997 | NC-907132 | NC-907132 | Detection of Syphilis | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI Syphilis Reference Sera |
41 | 00816057020638 | NC-870096-AG | NC-870096-AG | Detection of Epstein Barr Nuclear Antigen | LSE | Epstein-Barr Virus, Other | 1 | ASI EBNA IgG EIA Test |
42 | 00816057020539 | NC-810096-AG | NC-810096-AG | Detection of Toxoplasma Antibody | LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 2 | ASI Toxoplasma IgG EIA Test |
43 | 00816057020393 | NC-5001000 | NC-5001000 | Detection of C-Reactive Protein | DCN | System, Test, C-Reactive Protein | 2 | ASI CRP Slide Test |
44 | 00816057020386 | NC-500100E | NC-500100E | Detection of C-Reactive Protein, Export | DCN | System, Test, C-Reactive Protein | 2 | ASI CRP Slide Test |
45 | 00816057020379 | NC-500100 | NC-500100 | Detection of C-Reactive Protein | DCN | System, Test, C-Reactive Protein | 2 | ASI CRP Slide Test |
46 | 00816057020362 | NC-500050E | NC-500050E | Detection of C-Reactive Protein, Export | DCN | System, Test, C-Reactive Protein | 2 | ASI CRP Slide Test |
47 | 00816057020355 | NC-500050 | NC-500050 | Detection of C-Reactive Protein | DCN | System, Test, C-Reactive Protein | 2 | ASI CRP Slide Test |
48 | 00816057020348 | NC-500025E | NC-500025E | Detection of C-Reactive Protein, Export | DCN | System, Test, C-Reactive Protein | 2 | ASI CRP Slide Test |
49 | 00816057020331 | NC-500025 | NC-500025 | Detection of C-Reactive Protein | DCN | System, Test, C-Reactive Protein | 2 | ASI CRP Slide Test |
50 | 00816057020058 | NC-2700-000 | NC-2700-000 | EIA microtiter plate analyzer | JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 | ASI Infinity Analyzer |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 15099590624897 | 34430 | 34430 | The Access Rubella IgG assay is a paramagnetic particle, chemiluminescent immuno The Access Rubella IgG assay is a paramagnetic particle, chemiluminescent immunoassay for the qualitative and quantitative determination of IgG antibodies to the rubella virus in human serum using the Access Immunoassay Systems. | Access Rubella IgG | BECKMAN COULTER, INC. |
2 | 15099590624880 | 33435 | 34435 | The Access Rubella IgG Calibrators are intended to calibrate the Access Rubella The Access Rubella IgG Calibrators are intended to calibrate the Access Rubella IgG assay for the qualitative and quantitative determination of IgG antibodies to the rubella virus in human serum using the Access Immunoassay Systems. | Access Rubella IgG Calibrators | BECKMAN COULTER, INC. |
3 | 15099590624873 | 34439 | 34439 | The Access Rubella IgG QC is intended for monitoring the system performance of t The Access Rubella IgG QC is intended for monitoring the system performance of the Access Rubella IgG assay. | Access Rubella IgG QC | BECKMAN COULTER, INC. |
4 | 10859035006245 | 84R2 | Alere Rubella-plus® | ALERE NORTH AMERICA, LLC | ||
5 | 10758750004997 | 8536195 | 8536195 | VITROS Immunodiagnostic Products Rubella IgG Reagent Pack | VITROS | ORTHO CLINICAL DIAGNOSTICS |
6 | 10758750004546 | 8209074 | 8209074 | VITROS Immunodiagnostic Products Rubella IgG Calibrators | VITROS | ORTHO CLINICAL DIAGNOSTICS |
7 | 10743816001034 | BSP-171-10-01 | BSP-171-10-01 | BioSign® Rubella card; 10 Test kit; CE | BioSign® Rubella card | PRINCETON BIOMEDITECH CORPORATION |
8 | 10743816001027 | BSP-171-35-01 | BSP-171-35-01 | BioSign® Rubella card; 35 Test kit; CE | BioSign® Rubella card | PRINCETON BIOMEDITECH CORPORATION |
9 | 05391516747011 | 2325361 | 2325361 | Captia™ Rubella IgM | Trinity Biotech | CLARK LABORATORIES, INC. |
10 | 05391516747004 | 2325301 | 2325301 | Captia™ Rubella IgG | Trinity Biotech | CLARK LABORATORIES, INC. |
11 | 05391516746878 | 828102 | Wash Buffer Concentrate Type I, 20X | Trinity Biotech | CLARK LABORATORIES, INC. | |
12 | 05391516746786 | 617134 | Serum Diluent Type I | Trinity Biotech | CLARK LABORATORIES, INC. | |
13 | 05391516746748 | 616134 | Serum Diluent Type I | Trinity Biotech | CLARK LABORATORIES, INC. | |
14 | 05391516746533 | 525700 | Substrate Solution (TMB) | Trinity Biotech | CLARK LABORATORIES, INC. | |
15 | 05391516746526 | 915401 | Stop Solution | Trinity Biotech | CLARK LABORATORIES, INC. | |
16 | 05391516746519 | 827102 | Wash Buffer Concentrate Type I, 20X | Trinity Biotech | CLARK LABORATORIES, INC. | |
17 | 05391516743457 | 2325360 | 2325360 | Captia™ Rubella IgM | Trinity Biotech | CLARK LABORATORIES, INC. |
18 | 05391516743440 | 2325350 | 2325350 | Captia™ Rubella IgM | Trinity Biotech | CLARK LABORATORIES, INC. |
19 | 05391516743433 | 2325300 | 2325300 | Captia™ Rubella IgG | Trinity Biotech | CLARK LABORATORIES, INC. |
20 | 04015630940257 | 07027796190 | 07027796190 | Elecsys Rubella IgM | ROCHE DIAGNOSTICS GMBH | |
21 | 04015630940240 | 07027770190 | 07027770190 | Elecsys Rubella IgG | ROCHE DIAGNOSTICS GMBH | |
22 | 04015630939275 | 4618831160 | 4618831160 | Elecsys Rubella IgM Immunoassay | ROCHE DIAGNOSTICS GMBH | |
23 | 04015630939251 | 4618793160 | 4618793160 | Elecsys Rubella IgG Immunoassay | ROCHE DIAGNOSTICS GMBH | |
24 | 03573026138585 | 30226 | VIDAS ® RUB IgG (RBG) assay is a quantitative IA intended for use on VIDAS fami VIDAS ® RUB IgG (RBG) assay is a quantitative IA intended for use on VIDAS family instrument in the determination of IgG antibodies to rubella virus in human serum. | VIDAS® RUB IgG | BIOMERIEUX SA | |
25 | 00850487007395 | RUB M | Q01-110 | Rubella virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) | SeraQuest | QUEST INTERNATIONAL, INC. |
26 | 00850487007388 | RUB G | Q01-100 | Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | SeraQuest | QUEST INTERNATIONAL, INC. |
27 | 00850487007074 | RUB G | Q01-100 | Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) | ReQuest | QUEST INTERNATIONAL, INC. |
28 | 00850487007067 | RUB M | Q01-110 | Rubella virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) | ReQuest | QUEST INTERNATIONAL, INC. |
29 | 00847865012577 | SW4.1_V1 | 6653860D | Manual & CDs, Rubella & CMV IgM IFU, SW4.1_v1, U.S Only | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
30 | 00847865011006 | SW4.1_V1 | 6653870D | Rubella & CMV IgM Assay Protocol File CD, SW4.1_v1 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
31 | 00847865010696 | 25174 | 25174 | Rubella IgM EIA | Bio-Rad Laboratories, Inc. | BIO-RAD LABORATORIES, INC. |
32 | 00847865010689 | 25173 | 25173 | Rubella IgG EIA | Bio-Rad Laboratories, Inc. | BIO-RAD LABORATORIES, INC. |
33 | 00847865003186 | SW4_ V3 | 6653870C | Rubella & CMV Assay Protocol File CD, SW4_v3 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
34 | 00847865003179 | SW4_V3 | 6653860C | Manual & CDs, Rubella & CMV IgM IFU, SW4_v3, US Only | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
35 | 00847865001175 | 6653850 | 6653850 | Rubella & CMV IgM Reagent Pack | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
36 | 00817273020211 | 720-380 | "720-380 VZV IgG Test Kit" | Diamedix | DIAMEDIX CORPORATION | |
37 | 00817273020204 | 720-370 | "720-370 Rubella IgM Test Kit" | Diamedix | DIAMEDIX CORPORATION | |
38 | 00817273020198 | 720-360 | "720-360 Rubella IgG Test Kit" | Diamedix | DIAMEDIX CORPORATION | |
39 | 00816057020522 | NC-800096-AM | NC-800096-AM | Detection of Rubella Virus Antibody | ASI Rubella IgM EIA Test | ARLINGTON SCIENTIFIC, INC. |
40 | 00816057020515 | NC-800096-AG | NC-800096-AG | Detection of Rubella Virus Antiboby | ASI Rubella IgG EIA Test | ARLINGTON SCIENTIFIC, INC. |
41 | 00811727015181 | T8004-96 | T8004-96 | Pointe Scientific, Inc. Rubella IgM is for the qualitative detection of human Ig Pointe Scientific, Inc. Rubella IgM is for the qualitative detection of human IgM antibodies to rubella virus in human serum by enzyme immunoassay, to aid in the diagnosis of rubella infection. A positive result is presumptive for the detection of anti-rubella IgM antibodies and presumptive for the diagnosis of acute or recent rubella infection. 96 tests | Pointe Scientific, Inc. Rubella IgM | POINTE SCIENTIFIC, INC. |
42 | 00811727015174 | T8003-96 | T8003-96 | Pointe Scientific, Inc. Rubella IgG is for the qualitative, semi-quantitative an Pointe Scientific, Inc. Rubella IgG is for the qualitative, semi-quantitative and quantitative detection of human IgG antibodies to rubella virus in human serum by enzyme immunoassay, to aid in the assessment of the patient's immunological response to rubella, and as a qualitative screening test to determine the immune status of individuals, including women of childbearing age. These reagents have not received FDA clearance for use in testing blood or plasma donors. 96 tests | Pointe Scientific, Inc. Rubella IgG | POINTE SCIENTIFIC, INC. |
43 | 00630414976730 | 10469599 | LRUBCM | Rubella IGG - IMMULITE - CTL | IMMULITE® Systems RUB CONTROL Rubella IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
44 | 00630414976716 | 10469597 | LRMCM | Rubella IGM - IMMULITE - CTL | IMMULITE® Systems RUM CONTROL Rubella IgM | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
45 | 00630414971582 | 10374044 | LKRM1(D) | IMMULITE®/IMMULITE® 1000 Systems Rubella IgM | IMMULITE®/IMMULITE® 1000 Systems Rubella IgM | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
46 | 00630414971469 | 10374021 | L2KRM2(D) | Rubella IgM Ab - IMMULITE - RGT - 200 tests | IMMULITE® 2000 Systems RUM Rubella IgM | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
47 | 00630414964614 | 10381292 | LKRUB1 | Rubella IgG Ab - IMMULITE - RGT - 100 Tests | IMMULITE®/IMMULITE® 1000 Systems RUB Rubella Quantitative IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
48 | 00630414962061 | 10381305 | L2KRUB6 | Rubella IgG Ab - IMMULITE - RGT - 600 Tests | IMMULITE® 2000 Systems RUB Rubella Quantitative IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
49 | 00630414962054 | 10381338 | L2KRUB2 | Rubella IgG Ab - IMMULITE - RGT - 200 Tests | IMMULITE® 2000 Systems RUB Rubella Quantitative IgG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
50 | 00630414600536 | 10995671 | 10995671 | Rubella IgG (Rub G) QC Kit Atellica IM - CLT 3 x 2 x 5.0mL | Atellica IM Rub G QC | SIEMENS HEALTHCARE DIAGNOSTICS INC. |