| 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 | 10758750030200 | 6844055 | 6844055 | VITROS Immunodiagnostic Products25-OH Vitamin D Total Calibrators | JIT | CALIBRATOR, SECONDARY | 2 | VITROS |
| 30 | 10758750009541 | 1681543 | 1681543 | VITROS Immunodiagnostic Products Cortisol Calibrators | JIS | CALIBRATOR, PRIMARY | 2 | VITROS |
| 31 | 10758750009411 | 1619360 | 1619360 | VITROS Immunodiagnostic Products Anemia Controls | JJY | Multi-analyte controls, all kinds (assayed) | 1 | VITROS |
| 32 | 10758750009404 | 1614965 | 1614965 | VITROS Immunodiagnostic Products Total T3 Calibrators | JIS | CALIBRATOR, PRIMARY | 2 | VITROS |
| 33 | 10758750009367 | 1540525 | 1540525 | VITROS Immunodiagnostic Products Vitamin B12 Calibrators | CDD | RADIOASSAY, VITAMIN B12 | 2 | VITROS |
| 34 | 10758750009237 | 1513266 | 1513266 | VITROS Immunodiagnostic Products Folate Reagent Pack 1/2 | CGN | ACID, FOLIC, RADIOIMMUNOASSAY | 2 | VITROS |
| 35 | 10758750009213 | 1487289 | 1487289 | VITROS Immunodiagnostic Products TSH Calibrators | JIT | CALIBRATOR, SECONDARY | 2 | VITROS |
| 36 | 10758750009145 | 1471481 | 1471481 | VITROS Immunodiagnostic Products T3 Uptake Reagent Pack | KHQ | RADIOASSAY, TRIIODOTHYRONINE UPTAKE | 2 | VITROS |
| 37 | 10758750009138 | 1453489 | 1453489 | VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2 | CDD | RADIOASSAY, VITAMIN B12 | 2 | VITROS |
| 38 | 10758750009077 | 1435205 | 1435205 | VITROS Immunodiagnostic Products Testosterone Reagent Pack | CDZ | RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE | 1 | VITROS |
| 39 | 10758750009053 | 1420025 | 1420025 | VITROS Immunodiagnostic Products Metabolism Controls | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | VITROS |
| 40 | 10758750009015 | 1410646 | 1410646 | VITROS Immunodiagnostic Products Total Thyroid Controls | JJY | Multi-analyte controls, all kinds (assayed) | 1 | VITROS |
| 41 | 10758750008995 | 1393396 | 1393396 | VITROS Immunodiagnostic Products Total T4 Calibrators | JIS | CALIBRATOR, PRIMARY | 2 | VITROS |
| 42 | 10758750008971 | 1387000 | 1387000 | VITROS Immunodiagnostic Products Free T4 Reagent Pack | CEC | RADIOIMMUNOASSAY, FREE THYROXINE | 2 | VITROS |
| 43 | 10758750008926 | 1372101 | 1372101 | VITROS Immunodiagnostic Products Anti-HAV IgM Calibrator | LOL | Hepatitis a test (antibody and igm antibody) | 2 | VITROS |
| 44 | 10758750008902 | 1350198 | 1350198 | VITROS Immunodiagnostic Products LH Reagent Pack | CEP | RADIOIMMUNOASSAY, LUTEINIZING HORMONE | 1 | VITROS |
| 45 | 10758750008834 | 1322528 | 1322528 | VITROS Immunodiagnostic Products Total T3 Reagent Pack | CDP | RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE | 2 | VITROS |
| 46 | 10758750008810 | 1318930 | 1318930 | VITROS Immunodiagnostic ProductsEstradiol Calibrators | JIS | CALIBRATOR, PRIMARY | 2 | VITROS |
| 47 | 10758750008803 | 1315654 | 1315654 | VITROS Immunodiagnostic Products Free Thyroid Controls | JJY | Multi-analyte controls, all kinds (assayed) | 1 | VITROS |
| 48 | 10758750008797 | 1315589 | 1315589 | VITROS Immunodiagnostic Products Free T3 Reagent Pack | CDP | RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE | 2 | VITROS |
| 49 | 10758750008766 | 1311075 | 1311075 | VITROS Immunodiagnostic Products Folate Calibrators | JIS | CALIBRATOR, PRIMARY | 2 | VITROS |
| 50 | 10758750008742 | 1306026 | 1306026 | VITROS Immunodiagnostic ProductsTestosterone Calibrators | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | VITROS |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | B2423825DHUE010 | 38-25DHU-E01 | 38-25DHU-E01 | The 25OH Vitamin D Total ELISA Test is intended for the quantitative determinati The 25OH Vitamin D Total ELISA Test is intended for the quantitative determination of 25-hydroxyvitamin D2 and D3 (25-OH D2 and 25-OH D3) in human serum. The results are to be used in conjunction with other clinical and laboratory findings to assess the Vitamin D status of a patient. | 25OH Vitamin D Total ELISA | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. |
| 2 | 30014613333951 | Vitamin D EIA | 8046 | MicroVue Vitamin D EIA | MicroVue | QUIDEL CORPORATION |
| 3 | 15099590226558 | A98856 | A98856 | The Access 25(OH) Vitamin D Total assay is a paramagnetic particle, chemilumines The Access 25(OH) Vitamin D Total assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total 25-hydroxyvitamin D [25(OH) vitamin D] levels in human serum and plasma using the UniCel DxI Immunoassay Systems. Results are to be used as an aid in the assessment of vitamin D sufficiency. | Access 25(OH) Vitamin D Total | BECKMAN COULTER, INC. |
| 4 | 15099590225964 | B24838 | B24838 | The Access 25(OH) Vitamin D Total assay is a paramagnetic particle, chemilumines The Access 25(OH) Vitamin D Total assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total 25-hydroxyvitamin D [25(OH) vitamin D] levels in human serum and plasma using the Access 2 Immunoassay Systems. Results are to be used as an aid in the assessment of vitamin D sufficiency. | Access 25(OH) Vitamin D Total | BECKMAN COULTER, INC. |
| 5 | 14560189213125 | N/A | ST AIA-PACK 25-OH Vitamin D | TOSOH CORPORATION | ||
| 6 | 10816467020157 | Vit. D Immunoassay | 25000068, 25000073 | 30 Test Vit. D Immunoassay Complete Kit w/Cal and Control | FastPack® IP Vitamin D Kit Complete | QUALIGEN INC. |
| 7 | 10758750030217 | 6844056 | 6844056 | VITROS Immunodiagnostic Products25-OH Vitamin D Total Reagent Pack | VITROS | ORTHO CLINICAL DIAGNOSTICS |
| 8 | 08809317540337 | FRVD-AP | FRVDAP 020 | It is used for the quantitative measurement of 25-hydroxy vitamin D and related It is used for the quantitative measurement of 25-hydroxy vitamin D and related hydroxylated metabolites in humna serum and plasma. | FREND | NANOENTEK, INC. |
| 9 | 07613336184615 | 09038078160 | 09038078160 | Vitamin D total G3 Elecsys cobas e 100 | Elecsys Vitamin D total III | ROCHE DIAGNOSTICS GMBH |
| 10 | 07613336172650 | 09038086190 | 09038086190 | Vitamin D total G3 Elecsys E2G 300 | Elecsys Vitamin D total III | ROCHE DIAGNOSTICS GMBH |
| 11 | 07613336129197 | 07464215160 | 07464215160 | Elecsys Vitamin D total II | ROCHE DIAGNOSTICS GMBH | |
| 12 | 05400569000230 | KAP1971 | 25OH Vitamin D Total ELISA | 25OH Vitamin D Total | DIASOURCE IMMUNOASSAYS S.A. SA | |
| 13 | 05060169695320 | IS-2520N | IDS-iSYS 25 VitDS Calibrator Set | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
| 14 | 05060169695283 | IS-2500N | IDS-iSYS 25 VitDS | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
| 15 | 05060169690622 | IS-2500 | IDS-iSYS 25 VitDS | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
| 16 | 05060169690455 | AC-57SF1 | 25-Hydroxy Vitamin Ds EIA | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
| 17 | 05060169690400 | IS-2700S | IDS-iSYS 25-Hydroxy Vitamin DS | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
| 18 | 05060169690349 | IS-2400 | IDS-iSYS 1,25-Dihydroxy Vitamin D | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
| 19 | 05060169690097 | AC-62F1 | 1,25-Dihydroxy Vitamin D EIA | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
| 20 | 05060169690028 | AA-54F2 | 1,25 Dihydroxy Vitamin D RIA | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
| 21 | 05060169690011 | AA-54F1 | 1,25 Dihydroxy Vitamin D RIA | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
| 22 | 05060169690004 | AA-35F1 | 25-Hydroxy Vitamin D RIA | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
| 23 | 04987270235089 | 235089 | Lumipulse G 25-OH Vitamin D Immunoreaction Cartridges | FUJIREBIO INC. | ||
| 24 | 04560189213142 | N/A | ST AIA-PACK 25-OH Vitamin D PRETREATMENT SET | TOSOH CORPORATION | ||
| 25 | 04049016097129 | EQ 6411-9601 | 25-OH Vitamin D ELISA | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 26 | 04015630940127 | 07028148190 | 07028148190 | Elecsys Vitamin D total II | ROCHE DIAGNOSTICS GMBH | |
| 27 | 04015630932429 | 6506780160 | 6506780160 | Elecsys Vitamin D Assay | ROCHE DIAGNOSTICS GMBH | |
| 28 | 03610521185987 | 4.3_v5 | 12006557 | BioPlex 2200 25-OH Vitamin D Assay Protocol File CD SW4.3_v5 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
| 29 | 03610521185970 | 4.3_v5 | 12006556 | Manual & CDs, BioPlex 2200 25-OH Vitamin D STND IFU | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
| 30 | 03610520524503 | SW4.2V3 | 6653765B | Manual & CDs, 25-OH Vitamin D IFU, SW4.2_v3 US Only | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
| 31 | 03610520507025 | 4.2_v3 | 12000926 | U.S. Only IFU, Manual & CDs, BioPlex 2200 25-OH Vitamin D IFU SW4.2_v3 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
| 32 | 03610520506349 | SW4.2 V3 | 6653775A | 25-OH Vitamin D Assay Protocol File CD, SW4.2_v3, US | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
| 33 | 00895160002601 | TF8148 | TF8148 | An in vitro diagnostic test for the determination of vitamin D in human serum an An in vitro diagnostic test for the determination of vitamin D in human serum and plasma specimen. | Fluoro-CheckTM Vitamin D | NANO-DITECH CORPORATION |
| 34 | 00847865011655 | 6653750 | 6653750 | 25-OH Vitamin D Reagent Pack | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
| 35 | 00842768037740 | 10706480 | RF634 | Dimension® EXL™ Total Vitamin D, 200 tests (4x50) | Dimension® EXL™ Total Vitamin D | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 36 | 00817302020175 | ST500 | ST500 | Vitamin D-direct w/ cal 1 x 100 tests | CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 Vitamin D CONTROL SET | CAROLINA LIQUID CHEMISTRIES CORPORATION |
| 37 | 00817302020168 | ST501 | ST501 | Vitamin D-direct control 2 x 2 mL (2 lev) | CAROLINA LIQUID CHEMISTRIES CORP.® CLC720 Vitamin D RGT KIT Product No. ST500 | CAROLINA LIQUID CHEMISTRIES CORPORATION |
| 38 | 00816870020419 | 7725-300 | 7725-300A | Monobind AccuBind Vitamin D ELISA Kit - 96 Wells | MONOBIND, INC. | |
| 39 | 00815762021718 | RDKAP1971 | RDKAP1971 | Human Total 25-OH Vitamin D IVD ELISA Kit | Research and Diagnostic Systems | RESEARCH AND DIAGNOSTIC SYSTEMS, INC. |
| 40 | 00630414600345 | 10995721 | 10995721 | Vitamin D total 25 (OH) (VitD) Diluent Atellica IM CONS (2PK) 2 x 5mL | Atellica IM VitD DIL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 41 | 00630414600338 | 10995720 | 10995720 | Vitamin D total 25(OH) (VitD) - Atellica IM - RGT - 500T | Atellica™ IM VitD | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 42 | 00630414600321 | 10995719 | 10995719 | Vitamin D total 25(OH) (VitD) - Atellica IM - RGT - 100T | Atellica™ IM VitD | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 43 | 00630414592503 | 10699201 | 10699201 | ADVIA Centaur® VITAMIN D TOTAL (VITD) ASSAY | ADVIA Centaur® VitD | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 44 | 00630414588773 | 10632114 | 10632114 | Vitamin D Diluent Bottle - CENTAUR - CONS - 1x25mL | ADVIA Centaur® VitD Diluent Bottle | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 45 | 00630414586212 | 10494100 | 10494100 | Vitamin D Diluent (2PK) - CENTAUR - CAL - 2x25mL | ADVIA Centaur® VitD DIL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 46 | 00630414293837 | 11206265 | 11206265 | Vitamin D total 25(OH) (VitD) - Atellica IM - RGT 500T | Atellica IM VitD | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 47 | 00630414234489 | 11201773 | 11201773 | Vitamin D total 25(OH) (VitD) - Atellica™ IM - RGT - 500T | Atellica IM VitD | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 48 | 00630414234472 | 11201772 | 11201772 | Vitamin D total 25(OH) (VitD) - Atellica™ IM - RGT - 100T | Atellica IM VitD | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 49 | 00380740142759 | 5P02-12 | 05P0212 | ARCHITECT 25-OH Vitamin D Controls | ARCHITECT | ABBOTT IRELAND |
| 50 | 00380740142742 | 5P02-02 | 05P0202 | ARCHITECT 25-OH Vitamin D Calibrators | ARCHITECT | ABBOTT IRELAND |