| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 10758750034895 | 6177750 | 6177750 | VITROS Immunodiagnostic ProductsAFP Calibrators | JIS | Calibrator, primary | 2 | VITROS |
| 2 | 10758750034819 | 6177745 | 6177745 | VITROS Immunodiagnostic Products AFP Reagent Pack | LOJ | KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER | 2 | VITROS |
| 3 | 10758750034659 | 6199330 | 6199330 | VITROS Immunodiagnostic ProductsProlactin Calibrators | JIS | Calibrator, primary | 2 | VITROS |
| 4 | 10758750034420 | 6199961 | 6199961 | VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Quantitative Calibrator | QKO | Reagent, coronavirus serological | VITROS | |
| 5 | 10758750034413 | 6199960 | 6199960 | VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Quantitative Reagent Pack | QKO | Reagent, coronavirus serological | VITROS | |
| 6 | 10758750034321 | 6199337 | 6199337 | VITROS Immunodiagnostic Products Prolactin Reagent Pack | CFT | RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN) | 1 | VITROS |
| 7 | 10758750034314 | 6199336 | 6199336 | VITROS Immunodiagnostic Products CK-MB Reagent Pack | JHX | FLUOROMETRIC METHOD, CPK OR ISOENZYMES | 2 | VITROS |
| 8 | 10758750033409 | 6199924 | 6199924 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Controls | QKO | Reagent, coronavirus serological | VITROS | |
| 9 | 10758750033393 | 6199923 | 6199923 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrator | QKO | Reagent, coronavirus serological | VITROS | |
| 10 | 10758750033386 | 6199922 | 6199922 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack | QKO | Reagent, coronavirus serological | VITROS | |
| 11 | 10758750033379 | 6199921 | 6199921 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Controls | QKO | Reagent, coronavirus serological | VITROS | |
| 12 | 10758750033362 | 6199920 | 6199920 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator | QKO | Reagent, coronavirus serological | VITROS | |
| 13 | 10758750033355 | 6199919 | 6199919 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack | QKO | Reagent, coronavirus serological | VITROS | |
| 14 | 10758750033317 | 6192256 | 6192256 | VITROS Immunodiagnostic Products NT-proBNP II Calibrators | JIT | Calibrator, secondary | 2 | VITROS |
| 15 | 10758750033300 | 6192255 | 6192255 | VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack | NBC | Test, natriuretic peptide | 2 | VITROS |
| 16 | 10758750033294 | 6195575 | 6195575 | VITROS Immunodiagnostic Products BRAHMS PCT Calibrator | PMT | Device to detect and measure procalcitonin (PCT) in human clinical specimens | 2 | VITROS |
| 17 | 10758750033287 | 6197735 | 6197735 | VITROS Immunodiagnostic Products BRAHMS PCT Reagent Pack | PMT | Device to detect and measure procalcitonin (PCT) in human clinical specimens | 2 | VITROS |
| 18 | 10758750033195 | 691 2265 | 691 2265 | VITROS Immunodiagnostic Products HIV Combo Controls (Anti-HIV-1 group O) | OHQ | Multi-analyte controls unassayed | 1 | VITROS |
| 19 | 10758750033171 | 691 2263 | 691 2263 | VITROS Immunodiagnostic Products HIV Combo Controls (HIV p24 Antigen) | OHQ | Multi-analyte controls unassayed | 1 | VITROS |
| 20 | 10758750033164 | 691 2261 | 691 2261 | VITROS Immunodiagnostic Products HIV Combo Controls (Negative, Anti-HIV-1, Anti-HIV-2) | OHQ | Multi-analyte controls unassayed | 1 | VITROS |
| 21 | 10758750032945 | 6905561 | 6905561 | VITROS Immunodiagnostic Products BRAHMS PCT Range Verifiers | PMT | Device to detect and measure procalcitonin (PCT) in human clinical specimens | 2 | VITROS |
| 22 | 10758750032938 | 6905560 | 6905560 | VITROS Immunodiagnostic Products BRAHMS PCT Controls | PMT | Device to detect and measure procalcitonin (PCT) in human clinical specimens | 2 | VITROS |
| 23 | 10758750032068 | 6844425 | 6844425 | VITROS Immunodiagnostic Products Insulin Reagent Pack | CFP | RADIOIMMUNOASSAY, IMMUNOREACTIVE INSULIN | 1 | VITROS |
| 24 | 10758750032051 | 6844424 | 6844424 | VITROS Immunodiagnostic Products C-peptide Calibrators | JIT | Calibrator, secondary | 2 | VITROS |
| 25 | 10758750032044 | 6844426 | 6844426 | VITROS Immunodiagnostic Products Insulin Calibrators | JIT | Calibrator, secondary | 2 | VITROS |
| 26 | 10758750032037 | 6844423 | 6844423 | VITROS Immunodiagnostic Products C-peptide Reagent Pack | JKD | RADIOIMMUNOASSAY, C-PEPTIDES OF PROINSULIN | 1 | VITROS |
| 27 | 10758750031597 | 6842782 | 6842782 | VITROS Immunodiagnostic Products HIV Combo Calibrator | MZF | Test, hiv detection | 2 | VITROS |
| 28 | 10758750031580 | 6842781 | 6842781 | VITROS Immunodiagnostic Products HIV Combo Reagent Pack | MZF | Test, hiv detection | 2 | VITROS |
| 29 | 10758750030217 | 6844056 | 6844056 | VITROS Immunodiagnostic Products25-OH Vitamin D Total Reagent Pack | MRG | SYSTEM, TEST, VITAMIN D | 2 | VITROS |
| 30 | 10758750030200 | 6844055 | 6844055 | VITROS Immunodiagnostic Products25-OH Vitamin D Total Calibrators | JIT | CALIBRATOR, SECONDARY | 2 | VITROS |
| 31 | 10758750009541 | 1681543 | 1681543 | VITROS Immunodiagnostic Products Cortisol Calibrators | JIS | CALIBRATOR, PRIMARY | 2 | VITROS |
| 32 | 10758750009411 | 1619360 | 1619360 | VITROS Immunodiagnostic Products Anemia Controls | JJY | Multi-analyte controls, all kinds (assayed) | 1 | VITROS |
| 33 | 10758750009404 | 1614965 | 1614965 | VITROS Immunodiagnostic Products Total T3 Calibrators | JIS | CALIBRATOR, PRIMARY | 2 | VITROS |
| 34 | 10758750009367 | 1540525 | 1540525 | VITROS Immunodiagnostic Products Vitamin B12 Calibrators | CDD | RADIOASSAY, VITAMIN B12 | 2 | VITROS |
| 35 | 10758750009237 | 1513266 | 1513266 | VITROS Immunodiagnostic Products Folate Reagent Pack 1/2 | CGN | ACID, FOLIC, RADIOIMMUNOASSAY | 2 | VITROS |
| 36 | 10758750009213 | 1487289 | 1487289 | VITROS Immunodiagnostic Products TSH Calibrators | JIT | CALIBRATOR, SECONDARY | 2 | VITROS |
| 37 | 10758750009145 | 1471481 | 1471481 | VITROS Immunodiagnostic Products T3 Uptake Reagent Pack | KHQ | RADIOASSAY, TRIIODOTHYRONINE UPTAKE | 2 | VITROS |
| 38 | 10758750009138 | 1453489 | 1453489 | VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2 | CDD | RADIOASSAY, VITAMIN B12 | 2 | VITROS |
| 39 | 10758750009077 | 1435205 | 1435205 | VITROS Immunodiagnostic Products Testosterone Reagent Pack | CDZ | RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE | 1 | VITROS |
| 40 | 10758750009053 | 1420025 | 1420025 | VITROS Immunodiagnostic Products Metabolism Controls | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | VITROS |
| 41 | 10758750009015 | 1410646 | 1410646 | VITROS Immunodiagnostic Products Total Thyroid Controls | JJY | Multi-analyte controls, all kinds (assayed) | 1 | VITROS |
| 42 | 10758750008995 | 1393396 | 1393396 | VITROS Immunodiagnostic Products Total T4 Calibrators | JIS | CALIBRATOR, PRIMARY | 2 | VITROS |
| 43 | 10758750008971 | 1387000 | 1387000 | VITROS Immunodiagnostic Products Free T4 Reagent Pack | CEC | RADIOIMMUNOASSAY, FREE THYROXINE | 2 | VITROS |
| 44 | 10758750008926 | 1372101 | 1372101 | VITROS Immunodiagnostic Products Anti-HAV IgM Calibrator | LOL | Hepatitis a test (antibody and igm antibody) | 2 | VITROS |
| 45 | 10758750008902 | 1350198 | 1350198 | VITROS Immunodiagnostic Products LH Reagent Pack | CEP | RADIOIMMUNOASSAY, LUTEINIZING HORMONE | 1 | VITROS |
| 46 | 10758750008834 | 1322528 | 1322528 | VITROS Immunodiagnostic Products Total T3 Reagent Pack | CDP | RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE | 2 | VITROS |
| 47 | 10758750008810 | 1318930 | 1318930 | VITROS Immunodiagnostic ProductsEstradiol Calibrators | JIS | CALIBRATOR, PRIMARY | 2 | VITROS |
| 48 | 10758750008803 | 1315654 | 1315654 | VITROS Immunodiagnostic Products Free Thyroid Controls | JJY | Multi-analyte controls, all kinds (assayed) | 1 | VITROS |
| 49 | 10758750008797 | 1315589 | 1315589 | VITROS Immunodiagnostic Products Free T3 Reagent Pack | CDP | RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE | 2 | VITROS |
| 50 | 10758750008766 | 1311075 | 1311075 | VITROS Immunodiagnostic Products Folate Calibrators | JIS | CALIBRATOR, PRIMARY | 2 | VITROS |
| 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. |