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 | 00816467020044 | Testo Cal | 25000014 | JIT | Calibrator, Secondary | 2 | Calibrator Kit - Testosterone | |
9 | 30816467020038 | Testo Immunoassay | 25000058 | 90 Test Ported Testo Immunoassay Kit | CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | FastPack® IP Testo Kit (90) | |
10 | 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) | |
11 | 10816467020034 | Testo Immunoassay | 25000009 | 50 Test Non-Ported Testo Immunoassay Kit | CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | FastPack® Testo Kit (50) | |
12 | 00816467020105 | hCG Cal | 25000035 | JIT | Calibrator, Secondary | 2 | Calibrator Kit – hCG | |
13 | 00816467020143 | Vit. D Verifier | 25000064, 25000074 | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | Method Verification Kit - Vitamin D | |
14 | 10816467020386 | SARS-CoV-2 IgG Immunoassay | 25000085 | 90 Test Kit SARS-CoV-2 IgG Immunoassay | QKO | Reagent, Coronavirus Serological | FastPack SARS-CoV-2 IgG | |
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 | 20816467020055 | FT4 Immunoassay | 25000043 | 30 Test Ported FT4 Immunoassay Kit | FastPack® IP Free T4 Kit (30) | QUALIGEN INC. |
2 | 15099590225834 | 33880 | 33880 | The Access Free T4 assay is a paramagnetic particle, chemiluminescent immunoassa The Access Free T4 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free thyroxine levels in human serum and plasma (heparin) using the Access Immunoassay Systems. | Access Free T4 | BECKMAN COULTER, INC. |
3 | 14560189210315 | N/A | ST AIA-PACK FT4 | TOSOH CORPORATION | ||
4 | 10758750008971 | 1387000 | 1387000 | VITROS Immunodiagnostic Products Free T4 Reagent Pack | VITROS | ORTHO CLINICAL DIAGNOSTICS |
5 | 10758750000029 | 1728872 | 1728872 | VITROS Immunodiagnostic Products Free T4 Calibrators | VITROS | ORTHO CLINICAL DIAGNOSTICS |
6 | 08809317540382 | FRT4-AP | FRT4AP 020 | It is used for the quantitative determination of free thyroxine(free t4) in huma It is used for the quantitative determination of free thyroxine(free t4) in human specimen using FREND System. | FREND | NANOENTEK, INC. |
7 | 08809317540191 | FREND Free T4 | FRT4 020 | It is used for the quantitative determination of free thyroxine(free t4) in huma It is used for the quantitative determination of free thyroxine(free t4) in human specimen using FREND System. | FREND | NANOENTEK, INC. |
8 | 06947145577988 | 130203016M | 130203016M | MAGLUMI 2000 FT4 | SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD. | |
9 | 06947145577971 | 130603016M | 130603016M | MAGLUMI 2000 FT4 | SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO., LTD. | |
10 | 04560189211209 | N/A | AIA-PACK FT4 Calibrator Set | TOSOH CORPORATION | ||
11 | 04015630939725 | 07027397190 | 07027397190 | Elecsys FT4 II | ROCHE DIAGNOSTICS GMBH | |
12 | 04015630934232 | 6437281160 | 6437281160 | Elecsys FT4 II Assay | ROCHE DIAGNOSTICS GMBH | |
13 | 03573026368982 | 30459-01 | VIDAS FT4 is an automated quantitative assay for use on the VIDAS instruments fo VIDAS FT4 is an automated quantitative assay for use on the VIDAS instruments for the determination of free thyroxine (FT4) in human serum or plas ma (lithium heparin). | VIDAS® FT4 US | BIOMERIEUX SA | |
14 | 00842768022098 | 10464523 | RF610 | LOCI Free Thyroxine Flex® reagent cartridge, 120 tests | Dimension® EXL™ LOCI® Module Flex® reagent cartridge FT4L | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
15 | 00842768015205 | 10445103 | K6410 | Free Thyroxine Flex® reagent cartridge, 200 tests | Dimension Vista® Flex® reagent cartridge FT4 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
16 | 00842768013799 | 10444910 | RF410 | Free Thyroxine Flex® reagent cartridge, 120 tests | Dimension® Heterogenous Immunoassay Module Flex® reagent cartridge FT4 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
17 | 00840239042668 | EIA-4266 | EIA-4266 | The Quantitative Determination of Free Thyroxine Concentration in Human Serum or The Quantitative Determination of Free Thyroxine Concentration in Human Serum or Plasma by a Microplate Enzyme Immunoassay. | Free Thyroxine (fT4) ELISA | DRG INTERNATIONAL INC |
18 | 00817830022504 | 06B257215 | 06B257215 | Radioimmunoassay for the quantitative determination of Free Thyroxine (T4) in hu Radioimmunoassay for the quantitative determination of Free Thyroxine (T4) in human plasma or serum. | Free T4 MAb 125I RIA Kit | MP BIOMEDICALS, LLC |
19 | 00817830022498 | 06B257214 | 06B257214 | Radioimmunoassay for the quantitative determination of Free Thyroxine (T4) in hu Radioimmunoassay for the quantitative determination of Free Thyroxine (T4) in human plasma or serum. | Free T4 MAb 125I RIA Kit | MP BIOMEDICALS, LLC |
20 | 00816870023182 | 1275-300 | 1275-300E | Monobind AccuLite Free T4 CLIA Kit - 960 Wells | MONOBIND, INC. | |
21 | 00816870023175 | 1275-300 | 1275-300D | Monobind AccuLite Free T4 CLIA Kit - 480 Wells | MONOBIND, INC. | |
22 | 00816870023168 | 1275-300 | 1275-300B | Monobind AccuLite Free T4 CLIA Kit - 192 Wells | MONOBIND, INC. | |
23 | 00816870023151 | 1275-300 | 1275-300A | Monobind AccuLite Free T4 CLIA Kit - 96 Wells | MONOBIND, INC. | |
24 | 00816870021744 | 1225-300 | 1225-300E | Monobind AccuBind Free T4 ELISA Kit - 960 Wells | MONOBIND, INC. | |
25 | 00816870021737 | 1225-300 | 1225-300D | Monobind AccuBind Free T4 ELISA Kit - 480 Wells | MONOBIND, INC. | |
26 | 00816870021720 | 1225-300 | 1225-300B | Monobind AccuBind Free T4 ELISA Kit - 192 Wells | MONOBIND, INC. | |
27 | 00816870021713 | 1225-300 | 1225-300A | Monobind AccuBind Free T4 ELISA Kit - 96 Wells | MONOBIND, INC. | |
28 | 00811727013156 | T1008-96 | T1008-96 | Free T4 for the quantitative determination of Free Thyroxine (fT4) concentration Free T4 for the quantitative determination of Free Thyroxine (fT4) concentration in human serum. FOR RESEARCH USE ONLY. NOT FOR USE IN DIAGNOSTIC PROCEDURES. 96 Tests. | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
29 | 00630414996868 | 10381622 | LKFT41 | Free T4 - IMMULITE - RGT - 100 Tests | IMMULITE®/IMMULITE® 1000 Systems F4 Free T4 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
30 | 00630414996851 | 10381677 | L2KFT46 | Free T4 - IMMULITE - RGT - 600 Tests | IMMULITE® 2000 Systems FT4 Free T4 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
31 | 00630414996844 | 10381678 | L2KFT42 | Free T4 - IMMULITE - RGT - 200 Tests | IMMULITE® 2000 Systems FT4 Free T4 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
32 | 00630414599977 | 10995684 | 10995684 | Total T4 (T4) Atellica IM - RGT 150T | Atellica IM T4 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
33 | 00630414599144 | 10995590 | 10995590 | Free T4 (FT4) Atellica IM - Master Curve Material Kit 7 x 1 x 1.0mL | Atellica IM FT4 MCM | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
34 | 00630414599137 | 10995589 | 10995589 | Free T4 (FT4) Atellica IM - RGT 50T | Atellica IM FT4 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
35 | 00630414599120 | 10995588 | 10995588 | Free T4 (FT4) Atellica IM - RGT 250T | Atellica IM FT4 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
36 | 00630414553429 | 10283434 | 6872319 | FT4 Master Curve Material Set - CENTAUR - CONS | ADVIA Centaur® FT4 MCM | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
37 | 00630414535432 | 10282220 | 6490114 | Free T4 (REF) - CENTAUR - RGT - 250 tests | ADVIA Centaur® FT4 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
38 | 00630414535425 | 10282219 | 6490106 | Free T4 - CENTAUR - RGT - 250 tests | ADVIA Centaur® FT4 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
39 | 00630414535418 | 10282218 | 6490092 | Free T4 - CENTAUR - RGT - 50 tests | ADVIA Centaur® FT4 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
40 | 00630414293851 | 11206313 | 11206313 | Free T4 (FT4) - Atellica IM - RGT 1250T | Atellica IM FT4 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
41 | 00630414293684 | 11206255 | 11206255 | Free T4 (FT4) - Atellica IM - RGT 250T | Atellica IM FT4 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
42 | 00380740121822 | 07P7030 | 07P7030 | Alinity i Free T4 Reagent Kit 1200 Tests | Alinity | ABBOTT IRELAND |
43 | 00380740121815 | 07P7020 | 07P7020 | Alinity i Free T4 Reagent Kit 200 Tests | Alinity | ABBOTT IRELAND |
44 | 00380740119812 | 7K65-39 | 07K6539 | ARCHITECT Free T4 Reagent Kit (500T) | ARCHITECT | ABBOTT IRELAND |
45 | 00380740119805 | 7K65-34 | 07K6534 | ARCHITECT Free T4 Reagent Kit (2000T) | ARCHITECT | ABBOTT IRELAND |
46 | 00380740119799 | 7K65-29 | 07K6529 | ARCHITECT Free T4 Reagent Kit (100T) | ARCHITECT | ABBOTT IRELAND |
47 | 00380740105938 | 7K65-35 | 07K6535 | ARCHITECT Free T4 Reagent Kit (500T) | ARCHITECT | ABBOTT IRELAND |
48 | 00380740081126 | 7K65-27 | 07K6527 | ARCHITECT Free T4 Reagent Kit (100T) | ARCHITECT | ABBOTT IRELAND |
49 | 00380740081065 | 7K65-32 | 07K6532 | ARCHITECT Free T4 Reagent Kit (2000T) | ARCHITECT | ABBOTT IRELAND |
50 | 00380740081034 | 7K65-02 | 07K6502 | ARCHITECT Free T4 Calibrators | ARCHITECT | ABBOTT IRELAND |