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 | 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 | 04049325006546 | RE62039. | RE62039. | Testosterone Luminescence Immunoassay - 10 x 96 Determinations | Testosterone Luminescence Immunoassay | IBL INTERNATIONAL GMBH |
2 | 04049325003545 | RE62031 | RE62031 | Testosterone Luminescence Immunoassay - 96 Determinations | Testosterone Luminescence Immunoassay | IBL INTERNATIONAL GMBH |
3 | 04015630940516 | 07258496190 | 07258496190 | Elecsys SHBG | ROCHE DIAGNOSTICS GMBH | |
4 | 04015630939817 | 07027915190 | 07027915190 | Elecsys Testosterone II | ROCHE DIAGNOSTICS GMBH | |
5 | 04015630939312 | 05200067160 | 05200067160 | Elecsys Testosterone II | ROCHE DIAGNOSTICS GMBH | |
6 | 04015630939305 | 3052001160 | 03052001160 | Elecsys SHBG | ROCHE DIAGNOSTICS GMBH | |
7 | 00850392007152 | BC-1115 | BC-1115 | The BioCheck Testosterone EIA Test Kit is intended for the quantitative determin The BioCheck Testosterone EIA Test Kit is intended for the quantitative determination of testosterone concentration in human serum. | BioCheck Testosterone EIA Test Kit | BIOCHECK, INC. |
8 | 00850039602276 | 1 Universal | 635 | Stopping Solution EIA 1 - 15mL | Pantex Universal | PANTEX |
9 | 00850039602269 | 1 Universal | 635 | Color Development Reagent EIA 1 - 15mL | Pantex Universal | PANTEX |
10 | 00850039602252 | P635ST | 635 | Salivary Testosterone EIA Assay Diluent | Pantex P635ST | PANTEX |
11 | 00850039602245 | P635ST | 635 | Salivary Testosterone EIA Conjugate Buffer | Pantex P635ST | PANTEX |
12 | 00850039602238 | P635ST | 635 | Salivary Testosterone EIA Antibody | Pantex P635ST | PANTEX |
13 | 00850039602221 | P635ST | 635 | Salivary Testosterone EIA HRP Enzyme | Pantex P635ST | PANTEX |
14 | 00850039602214 | P635ST | 635 | Salivary Testosterone EIA Stock Control (20,000 pg/mL) | Pantex P635ST | PANTEX |
15 | 00850039602207 | P635ST | 635 | Salivary Testosterone EIA Stock Calibrator (62,500 pg/mL) | Pantex P635ST | PANTEX |
16 | 00842768026485 | 10488399 | K6465 | LOCI Total Testosterone Flex® reagent cartridge, 320 tests | Dimension Vista® Total Testosterone Flex® Reagent Cartridge | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
17 | 00840239061010 | EIA-6101 | EIA-6101 | The device is an Enzyme Immunoassay (EIA) for the quantitative measurement of fr The device is an Enzyme Immunoassay (EIA) for the quantitative measurement of free testosterone in human serum. s and adrogenital syndromes. | Free Testosterone ELISA | DRG INTERNATIONAL INC |
18 | 00840239046383 | EIA-4638 | EIA-4638 | For the direct quantitative determination of Free Testosterone by enzyme immunoa For the direct quantitative determination of Free Testosterone by enzyme immunoassay in human serum. For in vitro diagnostic use only. | Free Testosterone ELISA | DRG INTERNATIONAL INC |
19 | 00816870022963 | 5375-300 | 5375-300B | Monobind AccuLite Free Testosterone CLIA Kit - 192 Wells | MONOBIND, INC. | |
20 | 00816870022956 | 5375-300 | 5375-300A | Monobind AccuLite Free Testosterone CLIA Kit - 96 Wells | MONOBIND, INC. | |
21 | 00816870022949 | 3775-300 | 3775-300B | Monobind AccuLite Testosterone CLIA Kit - 192 Wells | MONOBIND, INC. | |
22 | 00816870022932 | 3775-300 | 3775-300A | Monobind AccuLite Testosterone CLIA Kit - 96 Wells | MONOBIND, INC. | |
23 | 00816870022925 | 9175-300 | 9175-300B | Monobind AccuLite SHBG CLIA Kit - 192 Wells | MONOBIND, INC. | |
24 | 00816870022918 | 9175-300 | 9175-300A | Monobind AccuLite SHBG CLIA Kit - 96 Wells | MONOBIND, INC. | |
25 | 00816870021522 | 5325-300 | 5325-300B | Monobind AccuBind Free Testosterone ELISA Kit - 192 Wells | MONOBIND, INC. | |
26 | 00816870021515 | 5325-300 | 5325-300A | Monobind AccuBind Free Testosterone ELISA Kit - 96 Wells | MONOBIND, INC. | |
27 | 00816870021508 | 3725-300 | 3725-300B | Monobind AccuBind Testosterone ELISA Kit - 192 Wells | MONOBIND, INC. | |
28 | 00816870021492 | 3725-300 | 3725-300A | Monobind AccuBind Testosterone ELISA Kit - 96 Wells | MONOBIND, INC. | |
29 | 00816870021485 | 9125-300 | 9125-300B | Monobind AccuBind SHBG ELISA Kit - 192 Wells | MONOBIND, INC. | |
30 | 00816870021478 | 9125-300 | 9125-300A | Monobind AccuBind SHBG ELISA Kit - 96 Wells | MONOBIND, INC. | |
31 | 00811727013309 | S1115-96 | S1115-96 | Testosterone for the quantitative determination of testosterone concentration in Testosterone for the quantitative determination of testosterone concentration in human serum. For in vitro diagnostic use only. 96 Tests. | Pointe Scientific, Inc. | POINTE SCIENTIFIC, INC. |
32 | 00811727013293 | S1113-96 | S1113-96 | Progesterone EIA Kit is for the quantitative determination of progesterone conce Progesterone EIA Kit is for the quantitative determination of progesterone concentrations in human serum or plasma. For in vitro diagnostic use only. | Pointe Scientific, Inc. Progesterone | POINTE SCIENTIFIC, INC. |
33 | 00630414998947 | 10285226 | LSHCM | SHBG - IMMULITE - CTL - 1x1x2mL | IMMULITE® SBG Control SHBG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
34 | 00630414972916 | 10381198 | L2KSH2 | SHBG - IMMULITE - RGT - 200 Tests | IMMULITE® 2000 Systems SBG SHBG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
35 | 00630414972831 | 10385366 | L1KSHW1 | SHBG Diluent - IMMULITE - CAL | IMMULITE® Systems SHBG DIL SHBG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
36 | 00630414966557 | 10381138 | LKSH1 | SHBG - IMMULITE - RGT - 100 Tests | IMMULITE®/IMMULITE® 1000 Systems SBG SHBG | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
37 | 00630414964782 | 10381156 | LKTW1 | Testosterone - IMMULITE - RGT - 100 Tests | IMMULITE®/IMMULITE® 1000 Systems TES Total Testosterone | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
38 | 00630414962221 | 10381191 | L2KTW6 | Testosterone - IMMULITE - RGT - 600 Tests | IMMULITE® 2000 Systems TES Total Testosterone | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
39 | 00630414962214 | 10381190 | L2KTW2 | Testosterone - IMMULITE - RGT - 200 Tests | IMMULITE® 2000 Systems TES Total Testosterone | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
40 | 00630414954226 | 10387041 | LSHZ | SHBG SAMPLE DILUENT - IMMULITE 2000 | IMMULITE®/IMMULITE® 1000 Systems SBG SHBG Sample Diluent | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
41 | 00630414954042 | 10283037 | LPHZ | PTH Sample Diluent - IMMULITE - CAL - 1x25mL | IMMULITE®/IMMULITE® 1000 Systems Sample Diluent PTH | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
42 | 00630414603391 | 10997191 | 10997191 | ADVIA Centaur Sex Hormone Binding Globulin (SHBG) - 50 tests - 1PK | ADVIA Centaur® SHBG | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
43 | 00630414600222 | 10995708 | 10995708 | Testoterone II (TSTII) Atellica IM - RGT 100T | Atellica IM TSTII | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
44 | 00630414600215 | 10995707 | 10995707 | Testoterone II (TSTII) Atellica IM - RGT 500T | Atellica IM TSTII | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
45 | 00630414599854 | 10995672 | 10995672 | Sex Hormone Binding Globulin (SHBG) Atellica IM - RGT 50T | Atellica IM SHBG | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
46 | 00630414591155 | 10696864 | 10696864 | Testosterone II (TSTII) - ADVIA Centaur® - RGT (REF) – 500T | ADVIA Centaur® TSTII | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
47 | 00630414591148 | 10696863 | 10696863 | Testosterone II - RGT - CENTAUR - 500 tests | ADVIA Centaur® TST II | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
48 | 00630414591131 | 10696862 | 10696862 | Testosterone II - RGT -100 Tests | ADVIA Centaur® TST II | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
49 | 00630414551548 | 10283087 | 6520781 | SHBG - CENTAUR - RGT - 50 tests | ADVIA Centaur® SHBG | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
50 | 00630414454658 | 10322623 | 125363 | Testosterone - CENTAUR - RGT - 250 tests | ADVIA Centaur® TSTO +E | SIEMENS HEALTHCARE DIAGNOSTICS INC. |