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 | 10758750009077 | 1435205 | 1435205 | VITROS Immunodiagnostic Products Testosterone Reagent Pack | CDZ | RADIOIMMUNOASSAY, TESTOSTERONES AND DIHYDROTESTOSTERONE | 1 | VITROS |
40 | 10758750009053 | 1420025 | 1420025 | VITROS Immunodiagnostic Products Metabolism Controls | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | VITROS |
41 | 10758750009015 | 1410646 | 1410646 | VITROS Immunodiagnostic Products Total Thyroid Controls | JJY | Multi-analyte controls, all kinds (assayed) | 1 | VITROS |
42 | 10758750008995 | 1393396 | 1393396 | VITROS Immunodiagnostic Products Total T4 Calibrators | JIS | CALIBRATOR, PRIMARY | 2 | VITROS |
43 | 10758750008971 | 1387000 | 1387000 | VITROS Immunodiagnostic Products Free T4 Reagent Pack | CEC | RADIOIMMUNOASSAY, FREE THYROXINE | 2 | VITROS |
44 | 10758750008926 | 1372101 | 1372101 | VITROS Immunodiagnostic Products Anti-HAV IgM Calibrator | LOL | Hepatitis a test (antibody and igm antibody) | 2 | VITROS |
45 | 10758750008902 | 1350198 | 1350198 | VITROS Immunodiagnostic Products LH Reagent Pack | CEP | RADIOIMMUNOASSAY, LUTEINIZING HORMONE | 1 | VITROS |
46 | 10758750008834 | 1322528 | 1322528 | VITROS Immunodiagnostic Products Total T3 Reagent Pack | CDP | RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE | 2 | VITROS |
47 | 10758750008810 | 1318930 | 1318930 | VITROS Immunodiagnostic ProductsEstradiol Calibrators | JIS | CALIBRATOR, PRIMARY | 2 | VITROS |
48 | 10758750008803 | 1315654 | 1315654 | VITROS Immunodiagnostic Products Free Thyroid Controls | JJY | Multi-analyte controls, all kinds (assayed) | 1 | VITROS |
49 | 10758750008797 | 1315589 | 1315589 | VITROS Immunodiagnostic Products Free T3 Reagent Pack | CDP | RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE | 2 | VITROS |
50 | 10758750008766 | 1311075 | 1311075 | VITROS Immunodiagnostic Products Folate Calibrators | JIS | CALIBRATOR, PRIMARY | 2 | VITROS |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 04015630940370 | 07251670190 | 07251670190 | Elecsys Anti-CCP | ROCHE DIAGNOSTICS GMBH | |
2 | 04015630939664 | 07027079190 | 07027079190 | Elecsys CEA | ROCHE DIAGNOSTICS GMBH | |
3 | 04015630938919 | 4491777160 | 4491777160 | Elecsys CEA Assay | ROCHE DIAGNOSTICS GMBH | |
4 | 04015630938766 | 11731629160 | 11731629160 | Elecsys CEA Assay | ROCHE DIAGNOSTICS GMBH | |
5 | 03573026229795 | 30453-01 | VIDAS ® CEA (S) (CEAS) is an automated quantitative test for use on the VIDAS in VIDAS ® CEA (S) (CEAS) is an automated quantitative test for use on the VIDAS instruments for the measurement of Carcinoembryonic antigen (CEA) in human serum. | VIDAS® CEA (S) | BIOMERIEUX SA | |
6 | 00842768019920 | 10461744 | K6453 | Carcinoembryonic Antigen Flex® reagent cartridge, 120 tests | Dimension Vista® Flex® reagent cartridge CEA | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
7 | 00816870022246 | 4675-300 | 4675-300B | Monobind AccuLite CEA Next Generation CLIA Kit - 192 Wells | MONOBIND, INC. | |
8 | 00816870022239 | 4675-300 | 4675-300A | Monobind AccuLite CEA Next Generation CLIA Kit - 96 Wells | MONOBIND, INC. | |
9 | 00816870022222 | 1875-300 | 1875-300B | Monobind AccuLite CEA CLIA Kit - 192 Wells | MONOBIND, INC. | |
10 | 00816870022215 | 1875-300 | 1875-300A | Monobind AccuLite CEA CLIA Kit - 96 Wells | MONOBIND, INC. | |
11 | 00816870020563 | 4625-300 | 4625-300B | Monobind AccuBind CEA Next Generation ELISA Kit - 192 Wells | MONOBIND, INC. | |
12 | 00816870020556 | 4625-300 | 4625-300A | Monobind AccuBind CEA Next Generation ELISA Kit - 96 Wells | MONOBIND, INC. | |
13 | 00816870020549 | 1825-300 | 1825-300B | Monobind AccuBind CEA ELISA Kit - 192 Wells | MONOBIND, INC. | |
14 | 00816870020532 | 1825-300 | 1825-300A | Monobind AccuBind CEA ELISA Kit - 96 Wells | MONOBIND, INC. | |
15 | 00630414963693 | 10380945 | LKCE1 | CEA - IMMULITE - RGT - 100 Tests | IMMULITE®/IMMULITE® 1000 Systems CEA | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
16 | 00630414961125 | 10380995 | L2KCE6 | CEA - IMMULITE - RGT - 600 Tests | IMMULITE® 2000 Systems CEA | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
17 | 00630414961118 | 10380994 | L2KCE2 | CEA - IMMULITE - RGT - 200 Tests | IMMULITE® 2000 Systems CEA | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
18 | 00630414953625 | 10387047 | LCEZ | CEA Sample Diluent - IMMULITE - 1x25mL | IMMULITE®/IMMULITE® 1000 Systems CEA CEA Sample Diluent | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
19 | 00630414598536 | 10995526 | 10995526 | CEA - Atellica IM - Master Curve Material Kit 6 x 1 x 1.0mL | Atellica IM CEA MCM | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
20 | 00630414598529 | 10995525 | 10995525 | CEA Diluent Atellica IM - CONS - (2PK) 2 x 5mL | Atellica IM CEA DIL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
21 | 00630414598512 | 10995524 | 10995524 | CEA Atellica IM - RGT - 500T | Atellica IM CEA | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
22 | 00630414598505 | 10995523 | 10995523 | CEA - Atellica IM - RGT - 100T | Atellica IM CEA | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
23 | 00630414293585 | 11206246 | 11206246 | CEA - Atellica IM - RGT 500T | Atellica IM CEA | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
24 | 00630414204741 | 10333162 | 118808 | Carcino-Embryonic Antigen (Ref) - CENTAUR - RGT - 500 tests | ADVIA Centaur® CEA | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
25 | 00630414177311 | 10309978 | 110762 | CEA - CENTAUR - RGT - 500 tests | ADVIA Centaur® CEA | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
26 | 00630414177304 | 10309977 | 110761 | CEA - CENTAUR - RGT - 100 tests | ADVIA Centaur® CEA | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
27 | 00630414175317 | 10309950 | 110322 | CEA Dil.RP (2PK) - CENTAUR - CAL - 2x5mL | ADVIA Centaur® CEA Diluent | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
28 | 00630414126302 | 10311624 | 672427000 | CEA Master Curve Material Set - CENTAUR - CONS | ADVIA Centaur® CEA MCM | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
29 | 00380740130862 | 07P6230 | 07P6230 | Alinity i CEA Reagent Kit 1200 Tests | Alinity | ABBOTT IRELAND DIAGNOSTICS |
30 | 00380740130855 | 07P6220 | 07P6220 | Alinity i CEA Reagent Kit 200 Tests | Alinity | ABBOTT IRELAND DIAGNOSTICS |
31 | 00380740130848 | 07P6210 | 07P6210 | Alinity i CEA Controls | Alinity | ABBOTT IRELAND DIAGNOSTICS |
32 | 00380740130831 | 07P6201 | 07P6201 | Alinity i CEA Calibrators | Alinity | ABBOTT IRELAND DIAGNOSTICS |
33 | 00380740112424 | 07K68-35 | 07K6835 | ARCHITECT CEA Reagent kit | ARCHITECT | ABBOTT IRELAND DIAGNOSTICS |
34 | 00380740014582 | 07K68-32 | 07K6832 | ARCHITECT CEA Reagent kit | ARCHITECT | ABBOTT IRELAND DIAGNOSTICS |
35 | 00380740014575 | 07K68-27 | 07K6827 | ARCHTECT CEA Reagent kit | ARCHITECT | ABBOTT IRELAND DIAGNOSTICS |
36 | 00380740014551 | 07K68-12 | 07K6812 | ARCHITECT CEA Controls | ARCHITECT | ABBOTT IRELAND DIAGNOSTICS |
37 | 00380740014544 | 07K68-02 | 07K6802 | ARCHITECT CEA Calibrators | ARCHITECT | ABBOTT IRELAND DIAGNOSTICS |
38 | 15099590624842 | 33200 | 33200 | The Access CEA assay is a paramagnentic particle, chemiluminescent immunoassay f The Access CEA assay is a paramagnentic particle, chemiluminescent immunoassay for the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum, using the Access Immunoassay Systems. | Access CEA | BECKMAN COULTER, INC. |
39 | 15099590624835 | 33205 | 33205 | The Access CEA Calibrators (BSA matrix) are intended to calibrate the Access CEA The Access CEA Calibrators (BSA matrix) are intended to calibrate the Access CEA assay for the quantitative determination of Carcinoembryonic Antigen (CEA) levels in human serum, using the Access Immunoassay Systems. | Access CEA Calibrators | BECKMAN COULTER, INC. |
40 | 15099590624828 | 33206 | 33206 | The Access CEA Diluent (BSA matrix) is intended for use with the Access CEA assa The Access CEA Diluent (BSA matrix) is intended for use with the Access CEA assay to dilute patient samples containing CEA concentrations greater than the Access CEA Calibrator S5 | Access CEA Diluent | BECKMAN COULTER, INC. |
41 | 15099590624811 | 33209 | 33209 | The Access CEA QC (BSA matrix) controls are intended for monitoring the system p The Access CEA QC (BSA matrix) controls are intended for monitoring the system performance of immunoenzymatic procedures for the quantitative measurement of Carcinoembryonic Antigen (CEA) using Access CEA reagents. | Access CEA QC | BECKMAN COULTER, INC. |
42 | 14560189210780 | N/A | ST AIA-PACK CEA | TOSOH CORPORATION | ||
43 | 10758750008353 | 1062306 | 1062306 | VITROS Immunodiagnostic Products CEA Calibrators | VITROS | ORTHO CLINICAL DIAGNOSTICS |
44 | 10758750000258 | 1920115 | 1920115 | VITROS Immunodiagnostic Products CEA Reagent Pack | VITROS | ORTHO CLINICAL DIAGNOSTICS |
45 | 04560189212244 | N/A | AIA-PACK CEA Calibration Verification Test Set | TOSOH CORPORATION | ||
46 | 04560189211780 | N/A | AIA-PACK CEA Sample Diluting Solution | TOSOH CORPORATION |