No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 10816467020157 | Vit. D Immunoassay | 25000068, 25000073 | 30 Test Vit. D Immunoassay Complete Kit w/Cal and Control | MRG | System, Test, Vitamin D | FastPack® IP Vitamin D Kit Complete | |
2 | 10816467020126 | hCG Immunoassay | 25000044 | 30 Test Ported hCG Immunoassay Kit | JHI | Visual, Pregnancy Hcg, Prescription Use | FastPack® IP hCG Kit (30) | |
3 | 10816467020010 | TPSA Immunoassay | 25000001 | 50 Test Non-Ported TPSA Immunoassay Kit | LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | FastPack® Total PSA Kit (50) | |
4 | 00816467020372 | Pro System | 08000067, 08000067-R, 08000067-X | RoHS Compliant 7-chamber FastPack System | JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 | FastPack® Pro System |
5 | 00816467020075 | TPSA Verifier | 25000017 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Method Verification Kit - PSA | |
6 | 20816467020086 | TSH Immunoassay | 25000042 | 30 Test Ported TSH Immunoassay Kit | JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | FastPack® IP TSH Kit (30) | |
7 | 00816467020167 | PSA Controls | 25000003 | Two levels of controls for the following assays: TPSA, FPSAFPSA is not available Two levels of controls for the following assays: TPSA, FPSAFPSA is not available in the US. | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Control Kit - PSA |
8 | 20816467020055 | FT4 Immunoassay | 25000043 | 30 Test Ported FT4 Immunoassay Kit | CEC | Radioimmunoassay, Free Thyroxine | FastPack® IP Free T4 Kit (30) | |
9 | 00816467020044 | Testo Cal | 25000014 | JIT | Calibrator, Secondary | 2 | Calibrator Kit - Testosterone | |
10 | 30816467020038 | Testo Immunoassay | 25000058 | 90 Test Ported Testo Immunoassay Kit | CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | FastPack® IP Testo Kit (90) | |
11 | 20816467020017 | TPSA Immunoassay | 25000040 | 30 Test Ported TPSA Immunoassay Kit | LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | FastPack® IP Total PSA Kit (30) | |
12 | 10816467020034 | Testo Immunoassay | 25000009 | 50 Test Non-Ported Testo Immunoassay Kit | CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | FastPack® Testo Kit (50) | |
13 | 00816467020105 | hCG Cal | 25000035 | JIT | Calibrator, Secondary | 2 | Calibrator Kit – hCG | |
14 | 00816467020143 | Vit. D Verifier | 25000064, 25000074 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Method Verification Kit - Vitamin D | |
15 | 00816467020020 | TPSA Cal | 25000002 | JIT | Calibrator, Secondary | 2 | Calibrator Kit - PSA | |
16 | 00816467020006 | IP System | 08000043, 08000043-R, 08000043-X | JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 | FastPack® IP System | |
17 | 00816467020099 | TSH Cal | 25000024 | JIT | Calibrator, Secondary | 2 | Calibrator Kit – TSH | |
18 | 00816467020068 | FT4 Cal | 25000016 | JIX | Calibrator, Multi-Analyte Mixture | 2 | Calibrator Kit – Free T4 | |
19 | 00816467020334 | IP System | 08000043-C, 08000043-CR | RoHS Compliant FastPack System | JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 | FastPack® IP System |
20 | 00816467020112 | hCG Diluent | 25000036 | Used to dilute the sample if the test result reads outside the assay range. Max Used to dilute the sample if the test result reads outside the assay range. Maximum two serial dilutions per sample. | JHI | Visual, Pregnancy Hcg, Prescription Use | 2 | FastPack® IP hCG Diluent Kit (25) |
21 | 20816467020031 | Testo Immunoassay | 25000041 | 30 Test Ported Testo Immunoassay Kit | CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | FastPack® IP Testo Kit (30) | |
22 | 00816467020136 | Multi-Analyte Controls | 25000056 | Two control levels for the following assays: TPSA, Testo, FT4, TSH, hCG | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | FastPack® Control Kit |
23 | 30816467020014 | TPSA Immunoassay | 25000057 | 90 Test Ported TPSA Immunoassay Kit | LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | FastPack® IP Total PSA Kit (90) | |
24 | 20816467020345 | FastPack® IP SHBG 30 Immunoassay | 25000081 | 30 Test SHBG Immunoassay Complete Kit w/Calibrator and Controls | JJX,JIT,CDZ | Single (Specified) Analyte Controls (Assayed And Unassayed),Calibrator, Secondar Single (Specified) Analyte Controls (Assayed And Unassayed),Calibrator, Secondary,Radioimmunoassay, Testosterones And Dihydrotestosterone | FastPack® IP SHBG | |
25 | 10816467020348 | FastPack® IP SHBG 60 Immunoassay | 25000080 | 60 Test SHBG Immunoassay Complete Kit w/Calibrator and Control | JJX,JIT,CDZ | Single (Specified) Analyte Controls (Assayed And Unassayed),Calibrator, Secondar Single (Specified) Analyte Controls (Assayed And Unassayed),Calibrator, Secondary,Radioimmunoassay, Testosterones And Dihydrotestosterone | FastPack® IP SHBG |
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 |