| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00380740059941 | 6E66-58 | 06E6658 | ABBOTT PRISM HBcore Wash Kit | ABBOTT PRISM | |||
| 2 | 00380740059934 | 3L68-58 | 03L6858 | ABBOTT PRISM HIV O Plus Wash Kit | ABBOTT PRISM | |||
| 3 | 00380740059927 | 7K35-58 | 07K3558 | ABBOTT PRISM Chagas Wash Kit | ABBOTT PRISM | |||
| 4 | 00380740050375 | 7A03-30 | 07A0330 | ABBOTT PRISM Purge Concentrate | MZA | TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN | ABBOTT PRISM | |
| 5 | 00380740027056 | 7A03-01 | 07A0301 | ABBOTT PRISM Prime/Purge Accessories | MZA | TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN | ABBOTT PRISM | |
| 6 | 00380740027001 | 1A75-01 | 01A7501 | ABBOTT PRISM Activator Diluent | ABBOTT PRISM | |||
| 7 | 00380740012403 | 7B36-01 | 07B3601 | ABBOTT PRISM SAMPLE CUPS | MZA | TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN | ABBOTT PRISM | |
| 8 | 00380740011604 | 7A03-31 | 07A0331 | ABBOTT PRISM Line Cleaner | MZA | TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN | ABBOTT PRISM | |
| 9 | 00380740008574 | 6A36-34 | 06A3634 | ABBOTT PRISM NEXT MAIN INSTRUMENT SIX CHANNEL | MZA | TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN | ABBOTT PRISM | |
| 10 | 00380740008420 | 6A36-11 | 06A3611 | ABBOTT PRISM NEXT MAIN INSTRUMENT SIX CHANNEL | MZA | TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN | ABBOTT PRISM | |
| 11 | 00380740007911 | 5A07-10 | 05A0710 | ABBOTT PRISM Pipette Tips | MZA | TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN | ABBOTT PRISM | |
| 12 | 00380740007904 | 5A07-01 | 05A0701 | ABBOTT PRISM Reaction Trays | MZA | TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN | ABBOTT PRISM | |
| 13 | 00380740168209 | 01P0603 | 01P0603 | Transplant Pretreatment Tubes | MLM,MKW,NRP | ENZYME IMMUNOASSAY, TRACROLIMUS,CYCLOSPORINE,Sirolimus test system | Alinity-Architect | |
| 14 | 00380740138400 | 3R97-02 | 03R9702 | ABBOTT PRISM Director Version 2.1 | MTQ | Software, blood virus applications | ABBOTT PRISM | |
| 15 | 00380740138394 | 3R97-01 | 03R9701 | ABBOTT PRISM Director Version 2.0 | MTQ | Software, blood virus applications | ABBOTT PRISM | |
| 16 | 00380740137922 | 09D2804 | 09D2804 | ICT Module | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | Alinity-Architect |
| 17 | 00380740063016 | 6E50-68 | 06E5068 | ABBOTT PRISM HTLV-I/HTLV-II Assay Kit | ABBOTT PRISM | |||
| 18 | 00380740062996 | 6D18-68 | 06D1868 | ABBOTT PRISM HCV Assay Kit | ABBOTT PRISM | |||
| 19 | 00380740062989 | 6D19-68 | 06D1968 | ABBOTT PRISM HBsAg Assay Kit | ABBOTT PRISM | |||
| 20 | 00380740062972 | 6E51-68 | 06E5168 | ABBOTT PRISM HBsAg Confirmatory Assay Kit | ABBOTT PRISM | |||
| 21 | 00380740062965 | 6E66-68 | 06E6668 | ABBOTT PRISM HBcore Assay Kit | ABBOTT PRISM | |||
| 22 | 00380740062958 | 3L68-68 | 03L6868 | ABBOTT PRISM HIV O Plus Assay Kit | ABBOTT PRISM | |||
| 23 | 00380740062941 | 7K35-68 | 07K3568 | ABBOTT PRISM Chagas Assay Kit | ABBOTT PRISM | |||
| 24 | 00380740038403 | 3E60-10 | 03E6010 | ABBOTT PRISM Run Control Kit | ABBOTT PRISM | |||
| 25 | 00380740059972 | 6E50-58 | 06E5058 | ABBOTT PRISM HTLV-I/HTLV-II Wash Kit | ABBOTT PRISM | |||
| 26 | 00380740059965 | 6D18-58 | 06D1858 | ABBOTT PRISM HCV Wash Kit | ABBOTT PRISM | |||
| 27 | 00380740059958 | 6D19-58 | 06D1958 | ABBOTT PRISM HBsAg Wash Kit | ABBOTT PRISM | |||
| 28 | 00380740039219 | 3E60-11 | 03E6011 | ABBOTT PRISM Positive Run Control Kit | ABBOTT PRISM | |||
| 29 | 00380740038380 | 6L86-10 | 06L8610 | ABBOTT PRISM Chagas Run Control Kit | ABBOTT PRISM | |||
| 30 | 00380740038373 | 1A75-10 | 01A7510 | ABBOTT PRISM Activator Line Treatment | MZA | TEST,EQUIPMENT,AUTOMATED BLOODBORNE PATHOGEN | ABBOTT PRISM | |
| 31 | 00380740030445 | 1A75-02 | 01A7502 | ABBOTT PRISM Activator Concentrate | ABBOTT PRISM | |||
| 32 | 00380740089535 | 8L34-68 | 08L3468 | ABBOTT ESA Chagas Assay Kit | ABBOTT | |||
| 33 | 00380740011635 | 7A12-60 | 07A1260 | XSYSTEMS TDx/TDx Flx Methotrexate II Reagent Pack | LAO | Enzyme immunoassay, methotrexate | U | ABBOTT |
| 34 | 00380740011628 | 7A12-10 | 07A1210 | XSYSTEMS TDx/TDx Flx Methotrexate II Controls | LAO | Enzyme immunoassay, methotrexate | U | ABBOTT |
| 35 | 00380740011611 | 7A12-01 | 07A1201 | XSYSTEMS TDx/TDx Flx Methotrexate II Calibrators | LAO | Enzyme immunoassay, methotrexate | U | ABBOTT |
| 36 | 00380740136093 | 04R1301 | 04R1301 | Emerald 22 Autoloader Analyzer | GKZ | Counter, differential cell | 2 | CELL-DYN |
| 37 | 00380740135737 | 99326-02 | 9932602 | CELL-DYN 1800 System DETERGENT | JCB | DETERGENT | 1 | CELL-DYN |
| 38 | 00380740135720 | 01H78-02 | 01H7802 | CELL-DYN Sapphire System WBC REAGENT - PART B | GGK | PRODUCTS, RED-CELL LYSING PRODUCTS | 1 | CELL-DYN |
| 39 | 00380740135713 | 01H77-02 | 01H7702 | CELL-DYN Sapphire System WBC REAGENT - PART A | GGK | PRODUCTS, RED-CELL LYSING PRODUCTS | 1 | CELL-DYN |
| 40 | 00380740120788 | 09H62-01 | 09H6201 | CELL-DYN Emerald 22 Diluent | GIF | DILUENT, BLOOD CELL | 1 | CELL-DYN |
| 41 | 00380740120771 | 09H6101 | 09H6101 | CELL-DYN Emerald 22 Lyse | GGK | PRODUCTS, RED-CELL LYSING PRODUCTS | 1 | CELL-DYN |
| 42 | 00380740120764 | 09H60-01 | 09H6001 | CELL-DYN Emerald 22 Easy Cleaner | JCB | DETERGENT | 1 | CELL-DYN |
| 43 | 00380740119843 | 09H73-01 | 09H7301 | CELL-DYN 22 Plus Calibrator | KRX | CALIBRATOR FOR CELL INDICES | 2 | CELL-DYN |
| 44 | 00380740119836 | 09H72-02 | 09H7202 | CELL-DYN 22 Plus Control | GLQ | MIXTURE, CONTROL, WHITE-CELL AND RED-CELL INDICES | 2 | CELL-DYN |
| 45 | 00380740119829 | 09H72-01 | 09H7201 | CELL-DYN 22 Plus Control | GLQ | MIXTURE, CONTROL, WHITE-CELL AND RED-CELL INDICES | 2 | CELL-DYN |
| 46 | 00380740099916 | 08H67-03 | 08H6703 | CELL-DYN Ruby | GKZ | Counter, differential cell | 2 | CELL-DYN |
| 47 | 00380740072643 | 07H84-02 | 07H8402 | CELL-DYN 1800 System CN-FREE DIFF LYSE | GGK | PRODUCTS, RED-CELL LYSING PRODUCTS | 1 | CELL-DYN |
| 48 | 00380740072445 | 99220-02 | 9922002 | CELL-DYN 1800 System DILUENT | GIF | DILUENT, BLOOD CELL | 1 | CELL-DYN |
| 49 | 00380740071141 | 07H77-01 | 07H7701 | CELL-DYN 1800 | GKZ | Counter, differential cell | 2 | CELL-DYN |
| 50 | 00380740021085 | 99644-01 | 9964401 | ENZYM CLNR 2X50 ML | JCB | DETERGENT | 1 | CELL-DYN |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 10816467020386 | SARS-CoV-2 IgG Immunoassay | 25000085 | 90 Test Kit SARS-CoV-2 IgG Immunoassay | FastPack SARS-CoV-2 IgG | QUALIGEN INC. |
| 2 | 10758750034581 | 6199976 | 6199976 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Calibrators | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| 3 | 10758750034567 | 6199975 | 6199975 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Reagent Pack | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| 4 | 10758750034420 | 6199961 | 6199961 | VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Quantitative Calibrator | VITROS | ORTHO CLINICAL DIAGNOSTICS |
| 5 | 10758750034413 | 6199960 | 6199960 | VITROS Immunodiagnostic Products Anti-SARS-COV-2 IgG Quantitative Reagent Pack | VITROS | ORTHO CLINICAL DIAGNOSTICS |
| 6 | 10758750033409 | 6199924 | 6199924 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Controls | VITROS | ORTHO CLINICAL DIAGNOSTICS |
| 7 | 10758750033393 | 6199923 | 6199923 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrator | VITROS | ORTHO CLINICAL DIAGNOSTICS |
| 8 | 10758750033386 | 6199922 | 6199922 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack | VITROS | ORTHO CLINICAL DIAGNOSTICS |
| 9 | 10758750033379 | 6199921 | 6199921 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Controls | VITROS | ORTHO CLINICAL DIAGNOSTICS |
| 10 | 10758750033362 | 6199920 | 6199920 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator | VITROS | ORTHO CLINICAL DIAGNOSTICS |
| 11 | 10758750033355 | 6199919 | 6199919 | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack | VITROS | ORTHO CLINICAL DIAGNOSTICS |
| 12 | 10722066005115 | COV-13C25 | COVID-19 IgG/IgM Test Cassette (Whole Blood/Serum/Plasma) | Rapid Response | BTNX INC | |
| 13 | 08809317540924 | FREND COVID-19 total Ab | FRCOA 020 | The COVID-19 total Ab is designed for the qualitative and quantitative measureme The COVID-19 total Ab is designed for the qualitative and quantitative measurement of anti-coronavirus IgG and IgM in human serum and plasma (Li-heparinized, EDTA,and citrate) by fluorescence immunoassay (FIA) using the FREND™ System. | FREND | NANOENTEK, INC. |
| 14 | 08809317540917 | COVID-19 total Ab Control LQ | FIC-COALQ | The COVID-19 total Ab Control LQ is designed to estimate the test and FREND™ COV The COVID-19 total Ab Control LQ is designed to estimate the test and FREND™ COVID-19 total Ab cartridges. COVID-19 total Ab Control LQ is not intended for use as a standard. | FREND | NANOENTEK, INC. |
| 15 | 08056771103664 | 311460 | LIAISON® SARS-CoV-2 S1/S2 IgG | DIASORIN SPA | ||
| 16 | 07333066021287 | DECC066630 | DECC066630 | EliA SARS-CoV-2-Sp1 IgG Well | EliA SARS-CoV-2-Sp1 IgG Well | PHADIA AB |
| 17 | 07333066021232 | 83-0042-11 | 83-0042-11 | EliA CoV Positive Control C1 250 | EliA CoV Positive Control C1 250 | PHADIA AB |
| 18 | 06973774259803 | 25 Tests/Kit | REF:207.01.25.02 | Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit | BIOHIT HEALTHCARE (HEFEI) CO., LTD. | |
| 19 | 06952804805029 | 1.0 | Fastep COVID-19 IgG/IgM Rapid Test Device | ASSURE TECH. (HANGZHOU) CO., LTD. | ||
| 20 | 05700571113011 | K1919 | SARS-CoV-2 IgG ELISA Kit | SARS-CoV-2 IgG ELISA Kit | AGILENT TECHNOLOGIES, INC. | |
| 21 | 05060169695962 | IS-ID6502 | IDS SARS-COV-2 IgG | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
| 22 | 04049016150244 | EI 2606-9601-20 G | Anti-SARS-CoV-2 S1 Curve ELISA (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 23 | 04049016145554 | EI 2606-9601 G | Anti-SARS-CoV-2 ELISA (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 24 | 04049016145547 | EI 2606-9601 A | Anti-SARS-CoV-2 ELISA (IgA) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 25 | 00682607200979 | L031-11711 | 200979 | Test Cassettes (25), 2.5mL Buffer Bottles (2), Droppers (25) | ACON SARS-CoV-2 IgG/IgM Rapid Test | ACON LABORATORIES, INC. |
| 26 | 00630414607139 | 11417771 | K7771 | Vista COV2G Assay | Vista COV2G Assay | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 27 | 00630414607030 | 11417770 | RF870 | Dimension CV2G Assay | Dimension CV2GAssay | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 28 | 00630414605500 | 11417414 | K7414 | Vista COV2T Assay | Vista COV2T Assay | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 29 | 00630414605494 | 11417413 | KC813 | DV/DM COV2T/CV2T CAL | DV/DM COV2T/CV2T CAL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 30 | 00630414605425 | 11417415 | KC815 | DV/DM COV2T/CV2T POS/NEG CTRL | DV/DM COV2T/CV2T POS/NEG CTRL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 31 | 00630414605418 | 11417412 | RF812 | Dimension CV2T Assay | Dimension CV2T Assay | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 32 | 00380740193867 | 06S6130 | 06S6130 | AdviseDx SARS-CoV-2 IgG II Reagent Kit 1000 Test | Alinity | ABBOTT IRELAND DIAGNOSTICS |
| 33 | 00380740193843 | 06S6120 | 06S6120 | AdviseDx SARS-CoV-2 IgG II Reagent Kit 200 Test | Alinity | ABBOTT IRELAND DIAGNOSTICS |
| 34 | 00380740193829 | 06S6110 | 06S6110 | AdviseDx SARS-CoV-2 IgG II Control Kit | Alinity | ABBOTT IRELAND DIAGNOSTICS |
| 35 | 00380740193805 | 06S6101 | 06S6101 | AdviseDx SARS-CoV-2 IgG II Calibrator Kit | Alinity | ABBOTT IRELAND DIAGNOSTICS |
| 36 | 00380740193782 | 06S6030 | 06S6030 | AdviseDx SARS-CoV-2 IgG II Reagent Kit 500 Test | ARCHITECT | ABBOTT IRELAND DIAGNOSTICS |
| 37 | 00380740193768 | 06S6020 | 06S6020 | AdviseDx SARS-CoV-2 IgG II Reagent Kit 100 Test | ARCHITECT | ABBOTT IRELAND DIAGNOSTICS |
| 38 | 00380740193744 | 06S6010 | 06S6010 | AdviseDx SARS-CoV-2 IgG II Control Kit | ARCHITECT | ABBOTT IRELAND DIAGNOSTICS |
| 39 | 00380740193720 | 06S6001 | 06S6001 | AdviseDx SARS-CoV-2 IgG II Calibrator Kit | ARCHITECT | ABBOTT IRELAND DIAGNOSTICS |
| 40 | 00380740192167 | 06R8730 | 06R8730 | AdviseDx SARS-CoV-2 IgM Reagent Kit 500 Test | ARCHITECT | ABBOTT IRELAND DIAGNOSTICS |
| 41 | 00380740192150 | 06R8630 | 06R8630 | SARS-CoV-2 IgG Reagent Kit 500 Tests | ARCHITECT | ABBOTT LABORATORIES |
| 42 | 00380740192136 | 06R9030 | 06R9030 | SARS-CoV-2 IgG Reagent Kit 1000 Tests | Alinity | ABBOTT LABORATORIES |
| 43 | 00380740192129 | 06R9020 | 06R9020 | SARS-CoV-2 IgG Reagent Kit 200 Tests | Alinity | ABBOTT LABORATORIES |
| 44 | 00380740192112 | 06R9010 | 06R9010 | SARS-CoV-2 IgG Control Kit | Alinity | ABBOTT LABORATORIES |
| 45 | 00380740192105 | 06R9001 | 06R9001 | SARS-CoV-2 IgG Calibrator Kit | Alinity | ABBOTT LABORATORIES |
| 46 | 00380740192099 | 06R9130 | 06R9130 | AdviseDx SARS-CoV-2 IgM Reagent Kit 1000 Test | Alinity | ABBOTT IRELAND DIAGNOSTICS |
| 47 | 00380740192082 | 06R9120 | 06R9120 | AdviseDx SARS-CoV-2 IgM Reagent Kit 200 Test | Alinity | ABBOTT IRELAND DIAGNOSTICS |
| 48 | 00380740192075 | 06R9110 | 06R9110 | AdviseDx SARS-CoV-2 IgM Control Kit | Alinity | ABBOTT IRELAND DIAGNOSTICS |
| 49 | 00380740192068 | 06R9101 | 06R9101 | AdviseDx SARS-CoV-2 IgM Calibrator Kit | Alinity | ABBOTT IRELAND DIAGNOSTICS |
| 50 | 00380740191863 | 06R8720 | 06R8720 | AdviseDx SARS-CoV-2 IgM Reagent Kit 100 Test | ARCHITECT | ABBOTT IRELAND DIAGNOSTICS |