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 | 10758750030217 | 6844056 | 6844056 | VITROS Immunodiagnostic Products25-OH Vitamin D Total Reagent Pack | MRG | SYSTEM, TEST, VITAMIN D | 2 | VITROS |
30 | 10758750030200 | 6844055 | 6844055 | VITROS Immunodiagnostic Products25-OH Vitamin D Total Calibrators | JIT | CALIBRATOR, SECONDARY | 2 | VITROS |
31 | 10758750009541 | 1681543 | 1681543 | VITROS Immunodiagnostic Products Cortisol Calibrators | JIS | CALIBRATOR, PRIMARY | 2 | VITROS |
32 | 10758750009411 | 1619360 | 1619360 | VITROS Immunodiagnostic Products Anemia Controls | JJY | Multi-analyte controls, all kinds (assayed) | 1 | VITROS |
33 | 10758750009404 | 1614965 | 1614965 | VITROS Immunodiagnostic Products Total T3 Calibrators | JIS | CALIBRATOR, PRIMARY | 2 | VITROS |
34 | 10758750009367 | 1540525 | 1540525 | VITROS Immunodiagnostic Products Vitamin B12 Calibrators | CDD | RADIOASSAY, VITAMIN B12 | 2 | VITROS |
35 | 10758750009237 | 1513266 | 1513266 | VITROS Immunodiagnostic Products Folate Reagent Pack 1/2 | CGN | ACID, FOLIC, RADIOIMMUNOASSAY | 2 | VITROS |
36 | 10758750009213 | 1487289 | 1487289 | VITROS Immunodiagnostic Products TSH Calibrators | JIT | CALIBRATOR, SECONDARY | 2 | VITROS |
37 | 10758750009145 | 1471481 | 1471481 | VITROS Immunodiagnostic Products T3 Uptake Reagent Pack | KHQ | RADIOASSAY, TRIIODOTHYRONINE UPTAKE | 2 | VITROS |
38 | 10758750009138 | 1453489 | 1453489 | VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2 | CDD | RADIOASSAY, VITAMIN B12 | 2 | 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 | B24211TESHUE010 | 11-TESHU-E01 | 11-TESHU-E01 | Intended for the direct quantitative determination of Testosterone by an enzyme Intended for the direct quantitative determination of Testosterone by an enzyme immunoassay in human serum. For in vitro diagnostic use. | Serum Testosterone ELISA | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. |
2 | B24211FTEHUE010 | 11-FTEHU-E01 | 11-FTEHU-E01 | For the direct quantitative determination of Free Testosterone by an enzyme immu For the direct quantitative determination of Free Testosterone by an enzyme immunoassay in human serum. For in vitro diagnostic use. | Free Testosterone ELISA | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. |
3 | 30816467020038 | Testo Immunoassay | 25000058 | 90 Test Ported Testo Immunoassay Kit | FastPack® IP Testo Kit (90) | QUALIGEN INC. |
4 | 20816467020345 | FastPack® IP SHBG 30 Immunoassay | 25000081 | 30 Test SHBG Immunoassay Complete Kit w/Calibrator and Controls | FastPack® IP SHBG | QUALIGEN INC. |
5 | 20816467020031 | Testo Immunoassay | 25000041 | 30 Test Ported Testo Immunoassay Kit | FastPack® IP Testo Kit (30) | QUALIGEN INC. |
6 | 15099590231347 | 33560 | 33560 | The Access Testosterone assay is a paramagnetic particle, chemiluminescent immun The Access Testosterone assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total testosterone levels in human serum and plasma using the Access Immunoassay Systems. | Access Testosterone | BECKMAN COULTER, INC. |
7 | 15099590231293 | 33565 | 33565 | The Access Testosterone Calibrators are intended to calibrate the Access Testost The Access Testosterone Calibrators are intended to calibrate the Access Testosterone assay for the quantitative determination of total testosterone levels in human serum and plasma using the Access Immunoassay Systems. | Access Testosterone Calibrator | BECKMAN COULTER, INC. |
8 | 15099590204037 | A48617 | A48617 | The Access SHBG assay is a paramagnetic particle, chemiluminescent immunoassay f The Access SHBG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Sex Hormone Binding Globulin levels in human serum and plasma using the Access Immunoassay Systems. | Access SHBG | BECKMAN COULTER, INC. |
9 | 14560189213354 | N/A | ST AIA-PACK SHBG | TOSOH CORPORATION | ||
10 | 14560189210032 | N/A | ST AIA-PACK Testosterone | TOSOH CORPORATION | ||
11 | 10816467020348 | FastPack® IP SHBG 60 Immunoassay | 25000080 | 60 Test SHBG Immunoassay Complete Kit w/Calibrator and Control | FastPack® IP SHBG | QUALIGEN INC. |
12 | 10816467020034 | Testo Immunoassay | 25000009 | 50 Test Non-Ported Testo Immunoassay Kit | FastPack® Testo Kit (50) | QUALIGEN INC. |
13 | 10758750009077 | 1435205 | 1435205 | VITROS Immunodiagnostic Products Testosterone Reagent Pack | VITROS | ORTHO CLINICAL DIAGNOSTICS |
14 | 08809317540375 | FRTE-AP | FRTEAP 020 | It is used for the quantitative measurement of Total Testosterone in human serum It is used for the quantitative measurement of Total Testosterone in human serum or heparinized, EDTA plasma sample. | FREND | NANOENTEK, INC. |
15 | 08809317540153 | FREND Testosterone | FRTE 020 | It is used for the quantitiative determination of Testosterone in human specimen It is used for the quantitiative determination of Testosterone in human specimen using FREND System. | FREND | NANOENTEK, INC. |
16 | 07613336170571 | 08946370190 | 08946370190 | Testosterone G2 Elecsys E2G 300 V2 | Elecsys Testosterone II | ROCHE DIAGNOSTICS GMBH |
17 | 07613336170557 | 08946353190 | 08946353190 | Testosterone G2 Elecsys cobas e 100 V2 | Elecsys Testosterone II | ROCHE DIAGNOSTICS GMBH |
18 | 05060169691322 | IS-5600 | IDS SHBG | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
19 | 04560189213388 | N/A | AIA-PACK SHBG CONTROL SET | TOSOH CORPORATION | ||
20 | 04560189213371 | N/A | ST AIA-PACK SHBG SAMPLE DILUTING SOLUTION | TOSOH CORPORATION | ||
21 | 04560189211346 | N/A | ST AIA-PACK Testosterone SAMPLE DILUTING SOLUTION | TOSOH CORPORATION | ||
22 | 04560189211339 | N/A | ST AIA-PACK Testosterone CALIBRATOR SET | TOSOH CORPORATION | ||
23 | 04049325006546 | RE62039. | RE62039. | Testosterone Luminescence Immunoassay - 10 x 96 Determinations | Testosterone Luminescence Immunoassay | IBL INTERNATIONAL GMBH |
24 | 04049325003545 | RE62031 | RE62031 | Testosterone Luminescence Immunoassay - 96 Determinations | Testosterone Luminescence Immunoassay | IBL INTERNATIONAL GMBH |
25 | 04015630940516 | 07258496190 | 07258496190 | Elecsys SHBG | ROCHE DIAGNOSTICS GMBH | |
26 | 04015630939817 | 07027915190 | 07027915190 | Elecsys Testosterone II | ROCHE DIAGNOSTICS GMBH | |
27 | 04015630939312 | 05200067160 | 05200067160 | Elecsys Testosterone II | ROCHE DIAGNOSTICS GMBH | |
28 | 04015630939305 | 3052001160 | 03052001160 | Elecsys SHBG | ROCHE DIAGNOSTICS GMBH | |
29 | 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. |
30 | 00850039602276 | 1 Universal | 635 | Stopping Solution EIA 1 - 15mL | Pantex Universal | PANTEX |
31 | 00850039602269 | 1 Universal | 635 | Color Development Reagent EIA 1 - 15mL | Pantex Universal | PANTEX |
32 | 00850039602252 | P635ST | 635 | Salivary Testosterone EIA Assay Diluent | Pantex P635ST | PANTEX |
33 | 00850039602245 | P635ST | 635 | Salivary Testosterone EIA Conjugate Buffer | Pantex P635ST | PANTEX |
34 | 00850039602238 | P635ST | 635 | Salivary Testosterone EIA Antibody | Pantex P635ST | PANTEX |
35 | 00850039602221 | P635ST | 635 | Salivary Testosterone EIA HRP Enzyme | Pantex P635ST | PANTEX |
36 | 00850039602214 | P635ST | 635 | Salivary Testosterone EIA Stock Control (20,000 pg/mL) | Pantex P635ST | PANTEX |
37 | 00850039602207 | P635ST | 635 | Salivary Testosterone EIA Stock Calibrator (62,500 pg/mL) | Pantex P635ST | PANTEX |
38 | 00842768026485 | 10488399 | K6465 | LOCI Total Testosterone Flex® reagent cartridge, 320 tests | Dimension Vista® Total Testosterone Flex® Reagent Cartridge | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
39 | 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 |
40 | 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 |
41 | 00816870022963 | 5375-300 | 5375-300B | Monobind AccuLite Free Testosterone CLIA Kit - 192 Wells | MONOBIND, INC. | |
42 | 00816870022956 | 5375-300 | 5375-300A | Monobind AccuLite Free Testosterone CLIA Kit - 96 Wells | MONOBIND, INC. | |
43 | 00816870022949 | 3775-300 | 3775-300B | Monobind AccuLite Testosterone CLIA Kit - 192 Wells | MONOBIND, INC. | |
44 | 00816870022932 | 3775-300 | 3775-300A | Monobind AccuLite Testosterone CLIA Kit - 96 Wells | MONOBIND, INC. | |
45 | 00816870022925 | 9175-300 | 9175-300B | Monobind AccuLite SHBG CLIA Kit - 192 Wells | MONOBIND, INC. | |
46 | 00816870022918 | 9175-300 | 9175-300A | Monobind AccuLite SHBG CLIA Kit - 96 Wells | MONOBIND, INC. | |
47 | 00816870021522 | 5325-300 | 5325-300B | Monobind AccuBind Free Testosterone ELISA Kit - 192 Wells | MONOBIND, INC. | |
48 | 00816870021515 | 5325-300 | 5325-300A | Monobind AccuBind Free Testosterone ELISA Kit - 96 Wells | MONOBIND, INC. | |
49 | 00816870021508 | 3725-300 | 3725-300B | Monobind AccuBind Testosterone ELISA Kit - 192 Wells | MONOBIND, INC. | |
50 | 00816870021492 | 3725-300 | 3725-300A | Monobind AccuBind Testosterone ELISA Kit - 96 Wells | MONOBIND, INC. |