No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00380740194079 | 04Z2135 | 04Z2135 | Alinity i STAT High Sensitivity Troponin-I Reagent Kit 1200 test | MMI | IMMUNOASSAY METHOD, TROPONIN SUBUNIT | 2 | Alinity |
2 | 00380740169862 | 03P6834 | 03P6834 | CC MAGNESIUM 3750 Tests | JGJ | PHOTOMETRIC METHOD, MAGNESIUM | 1 | ARCHITECT |
3 | 00380740169855 | 03P6824 | 03P6824 | CC MAGNESIUM 1000 Tests | JGJ | PHOTOMETRIC METHOD, MAGNESIUM | 1 | ARCHITECT |
4 | 00380740164980 | 04V6201 | 04V6201 | Consolidated Chemistry Calibrator | JIX | Calibrator, multi-analyte mixture | 2 | Alinity |
5 | 00380740164973 | 04V1501 | 04V1501 | Consolidated Chemistry Calibrator | JIX | Calibrator, multi-analyte mixture | 2 | ARCHITECT |
6 | 00380740160623 | 07P5131 | 07P5131 | Alinity i Total B-hCG Reagent Kit 1200 Tests | DHA | SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN | 2 | Alinity |
7 | 00380740160616 | 07P5121 | 07P5121 | Alinity i Total B-hCG Reagent Kit | DHA | SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN | 2 | Alinity |
8 | 00380740158743 | 04U0930 | 04U0930 | Uric Acid2 2000 Tests | KNK | Acid, uric, uricase (colorimetric) | 1 | Alinity |
9 | 00380740158378 | 04U0920 | 04U0920 | Uric Acid2 640 Tests | KNK | Acid, uric, uricase (colorimetric) | 1 | Alinity |
10 | 00380740158361 | 04T1330 | 04T1330 | Uric Acid2 2000 Tests | CDO | Acid, uric, uricase (u.V.) | 1 | ARCHITECT |
11 | 00380740158354 | 04T1320 | 04T1320 | Uric Acid2 640 Tests | CDO | Acid, uric, uricase (u.V.) | 1 | ARCHITECT |
12 | 00380740158064 | 04T8630 | 04T8630 | Aspartate Aminotransferase2 3120 Tests | CIT | Nadh oxidation/nad reduction, ast/sgot | 2 | Alinity |
13 | 00380740158057 | 04T8620 | 04T8620 | Aspartate Aminotransferase2 1200 Tests | CIT | Nadh oxidation/nad reduction, ast/sgot | 2 | Alinity |
14 | 00380740155902 | 04T0030 | 04T0030 | Gamma-Glutamyl Transferase2 2600 Tests | JPZ | COLORIMETRIC METHOD, GAMMA-GLUTAMYL TRANSPEPTIDASE | 1 | ARCHITECT |
15 | 00380740155896 | 04T0020 | 04T0020 | Gamma-Glutamyl Transferase2 600 Tests | JPZ | COLORIMETRIC METHOD, GAMMA-GLUTAMYL TRANSPEPTIDASE | 1 | ARCHITECT |
16 | 00380740155759 | 04T9030 | 04S9030 | Aspartate Aminotransferase2 3960 Tests | CIT | Nadh oxidation/nad reduction, ast/sgot | 2 | ARCHITECT |
17 | 00380740155742 | 04S8830 | 04S8830 | Alanine Aminotransferase2 3960 Tests | CKA | NADH OXIDATION/NAD REDUCTION, ALT/SGPT | 1 | ARCHITECT |
18 | 00380740155735 | 04T9020 | 04S9020 | Aspartate Aminotransferase2 1200 Tests | CIT | Nadh oxidation/nad reduction, ast/sgot | 2 | ARCHITECT |
19 | 00380740155728 | 04S8820 | 04S8820 | Alanine Aminotransferase2 1200 Tests | CKA | NADH OXIDATION/NAD REDUCTION, ALT/SGPT | 1 | ARCHITECT |
20 | 00380740155711 | 04T8430 | 04T8430 | Alanine Aminotransferase2 3120 Tests | CKA | NADH OXIDATION/NAD REDUCTION, ALT/SGPT | 1 | Alinity |
21 | 00380740155704 | 04T8420 | 04T8420 | Alanine Aminotransferase2 1200 Tests | CKA | NADH OXIDATION/NAD REDUCTION, ALT/SGPT | 1 | Alinity |
22 | 00380740155476 | 04U4430 | 04U4430 | Total Protein2 3200 Tests | CEK | BIURET (COLORIMETRIC), TOTAL PROTEIN | 2 | ARCHITECT |
23 | 00380740155469 | 04U4420 | 04U4420 | Total Protein2 800 Tests | CEK | BIURET (COLORIMETRIC), TOTAL PROTEIN | 2 | ARCHITECT |
24 | 00380740155315 | 04T9630 | 04T9630 | Gamma-Glutamyl Transferase2 2100 Tests | JPZ | COLORIMETRIC METHOD, GAMMA-GLUTAMYL TRANSPEPTIDASE | 1 | Alinity |
25 | 00380740155308 | 04T9620 | 04T9620 | Gamma-Glutamyl Transferase2 600 Tests | JPZ | COLORIMETRIC METHOD, GAMMA-GLUTAMYL TRANSPEPTIDASE | 1 | Alinity |
26 | 00380740155278 | 04T8130 | 04T8130 | Total Protein2 3120 Tests | CEK | BIURET (COLORIMETRIC), TOTAL PROTEIN | 2 | Alinity |
27 | 00380740155261 | 04T8120 | 04T8120 | Total Protein2 800 Tests | CEK | BIURET (COLORIMETRIC), TOTAL PROTEIN | 2 | Alinity |
28 | 00380740146221 | 08P4512 | 08P4512 | Alinity i 25-OH Vitamin D Controls | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Alinity |
29 | 00380740144883 | 07K6437 | 07K6437 | ARCHITECT Total T3 Reagent Kit (500T) | CDP | RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE | 2 | ARCHITECT |
30 | 00380740144876 | 07K6432 | 07K6432 | ARCHITECT Total T3 Reagent Kit (2000T) | CDP | RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE | 2 | ARCHITECT |
31 | 00380740144869 | 07K6427 | 07K6427 | ARCHITECT Total T3 Reagent Kit (100T) | CDP | RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE | 2 | ARCHITECT |
32 | 00380740144845 | 07K6402 | 07K6402 | ARCHITECT Total T3 Calibrators | JIT | Calibrator, secondary | 2 | ARCHITECT |
33 | 00380740144838 | 07K6337 | 07K6337 | ARCHITECT Free T3 Reagent Kit (500T) | CDP | RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE | 2 | ARCHITECT |
34 | 00380740144821 | 07K6332 | 07K6332 | ARCHITECT Free T3 Reagent Kit (2000T) | CDP | RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE | 2 | ARCHITECT |
35 | 00380740144814 | 07K6327 | 07K6327 | ARCHITECT Free T3 Reagent Kit (100T) | CDP | RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE | 2 | ARCHITECT |
36 | 00380740144807 | 07K6312 | 07K6312 | ARCHITECT Free T3 Controls | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | ARCHITECT |
37 | 00380740144791 | 07K6302 | 07K6302 | ARCHITECT Free T3 Calibrators | JIT | Calibrator, secondary | 2 | ARCHITECT |
38 | 00380740142759 | 5P02-12 | 05P0212 | ARCHITECT 25-OH Vitamin D Controls | MRG,JJX,JIT | SYSTEM, TEST, VITAMIN D,Single (specified) analyte controls (assayed and unassay SYSTEM, TEST, VITAMIN D,Single (specified) analyte controls (assayed and unassayed),CALIBRATOR, SECONDARY | 1 | ARCHITECT |
39 | 00380740142742 | 5P02-02 | 05P0202 | ARCHITECT 25-OH Vitamin D Calibrators | JIT,JJX,MRG | CALIBRATOR, SECONDARY,Single (specified) analyte controls (assayed and unassayed CALIBRATOR, SECONDARY,Single (specified) analyte controls (assayed and unassayed),SYSTEM, TEST, VITAMIN D | 1 | ARCHITECT |
40 | 00380740136710 | 08P3640 | 08P3640 | Alinity i Progesterone Manual Diluent | JLS | RADIOIMMUNOASSAY, PROGESTERONE | 1 | Alinity |
41 | 00380740136703 | 07P6731 | 07P6731 | Alinity i B12 Reagent Kit 1200 Tests | CDD | RADIOASSAY, VITAMIN B12 | 2 | Alinity |
42 | 00380740136697 | 07P6721 | 07P6721 | Alinity i B12 Reagent Kit 200 Tests | CDD | RADIOASSAY, VITAMIN B12 | 2 | Alinity |
43 | 00380740136680 | 07P6712 | 07P6712 | Alinity i B12 Controls | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Alinity |
44 | 00380740136673 | 07P6702 | 07P6702 | Alinity i B12 Calibrators | JIT | Calibrator, secondary | 2 | Alinity |
45 | 00380740136567 | 08P1431 | 08P1431 | Alinity i Folate Reagent Kit 1200 Tests | CGN | ACID, FOLIC, RADIOIMMUNOASSAY | 2 | Alinity |
46 | 00380740136550 | 08P1421 | 08P1421 | Alinity i Folate Reagent Kit 200 Tests | CGN | ACID, FOLIC, RADIOIMMUNOASSAY | 2 | Alinity |
47 | 00380740136543 | 08P1412 | 08P1412 | Alinity i Folate Controls | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Alinity |
48 | 00380740136536 | 08P1402 | 08P1402 | Alinity i Folate Calibrators | JIT | Calibrator, secondary | 2 | Alinity |
49 | 00380740131647 | 07P4930 | 07P4930 | Alinity i FSH Reagent Kit 1200 Tests | CGJ | RADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE | 1 | Alinity |
50 | 00380740131630 | 07P4920 | 07P4920 | Alinity i FSH Reagent Kit 200 Tests | CGJ | RADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE | 1 | Alinity |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 10796918001808 | 05-8575 | INSTANT-VIEW Troponin I Whole Blood/Serum Test (Cassette) | INSTANT-VIEW Troponin I Whole Blood/Serum Test (Cassette) | ALFA SCIENTIFIC DESIGNS, INC. | |
2 | 10796918001792 | 05-8572 | INSTANT-VIEW Troponin I Serum Cassette Test | INSTANT-VIEW Troponin I Serum Cassette Test | ALFA SCIENTIFIC DESIGNS, INC. | |
3 | 10758750002504 | 6802301 | 6802301 | VITROS Immunodiagnostic Products Troponin I ES Reagent Pack | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
4 | 10743816001348 | LSC-300-01-00 | LSC-300-01-00 | LifeSign® MI StatusFirst CK-MB/Myo/TnI; 1 Test kit; CE; Multilanguage | LifeSign® MI StatusFirst CK-MB/Myo/TnI card | PRINCETON BIOMEDITECH CORPORATION |
5 | 10743816001331 | LSC-300-20-02 | LSC-300-20-02 | LifeSign® MI StatusFirst CK-MB/Myo/TnI; 20 Test kit; CE | LifeSign® MI StatusFirst CK-MB/Myo/TnI card | PRINCETON BIOMEDITECH CORPORATION |
6 | 10743816001324 | LSC-300-20-00 | LSC-300-20-00 | LifeSign® MI CK-MB/Myo/TnI; 20 Test kit | LifeSign® MI CK-MB/Myo/TnI card | PRINCETON BIOMEDITECH CORPORATION |
7 | 10743816001294 | LSC-210-20-00 | LSC-210-20-00 | LifeSign® MI Myo/TnI; 20 Test kit | LifeSign® MI Myo/TnI card | PRINCETON BIOMEDITECH CORPORATION |
8 | 10743816001263 | LSC-131-20-00 | LSC-131-20-00 | StatusFirst™ Tn I; Quantitative; 20 Test kit; CE | StatusFirst™ Tn I card | PRINCETON BIOMEDITECH CORPORATION |
9 | 10743816001256 | LSC-130-01-00 | LSC-130-01-00 | LifeSign® MI StatusFirst Troponin I; 1 Test kit; CE; Multilanguage | LifeSign® MI StatusFirst Troponin I card | PRINCETON BIOMEDITECH CORPORATION |
10 | 10743816001249 | LSC-130-20-00 | LSC-130-20-00 | LifeSign® MI Troponin I; 20 Test kit | LifeSign® MI Troponin I card | PRINCETON BIOMEDITECH CORPORATION |
11 | 10054749001986 | 06P23-25 | 06P23-25 | CARTRIDGE, cTnI | i-STAT | ABBOTT POINT OF CARE INC. |
12 | 10054749000187 | 03P90-25 | 03P90-25 | TROPONIN CARTRIDGE | i-STAT | ABBOTT POINT OF CARE INC. |
13 | 08305900070316 | 7031 | The cTnI ELISA is intended for the quantitative determination of cardiac troponi The cTnI ELISA is intended for the quantitative determination of cardiac troponin I in human serum. Measurement of troponin I values are useful in the evaluation of acute myocardial infarction (AMI). | TROPONIN I (HUMAN CARDIAC-SPECIFIC) ENZYME IMMUNOASSAY TEST KIT | BIOMERICA, INC. | |
14 | 07613336158982 | 08469890160 | 08469890160 | Elecsys Troponin T Gen 5 | ROCHE DIAGNOSTICS GMBH | |
15 | 07613336158951 | 08469865160 | 08469865160 | Troponin T G5 STAT Elecsys cobas e100 V2 (E1G) | Elecsys Troponin T Gen 5 | ROCHE DIAGNOSTICS GMBH |
16 | 07613336148273 | 08250472160 | 08250472160 | Elecsys Troponin T Gen 5 | ROCHE DIAGNOSTICS GMBH | |
17 | 04987595301131 | N/A | PATHFAST cTnI-II | LSI MEDIENCE CORPORATION | ||
18 | 04560189211049 | N/A | ST AIA-PACK cTnI 2 Sample Dilting Solution | TOSOH CORPORATION | ||
19 | 04015630942695 | 07398000160 | 07398000160 | Elecsys Troponin T Gen 5 STAT | ROCHE DIAGNOSTICS GMBH | |
20 | 04015630939381 | 5094798160 | 5094798160 | Elecsys Troponin I STAT Immunoassay | ROCHE DIAGNOSTICS GMBH | |
21 | 04015630939374 | 5094810160 | 5094810160 | Elecsys Troponin I Immunoassay | ROCHE DIAGNOSTICS GMBH | |
22 | 04015630922475 | 4856643190 | 4856643190 | Elecsys Troponin T STAT CalSet | ROCHE DIAGNOSTICS GMBH | |
23 | 04015630922468 | 4856627190 | 4856627190 | Elecsys Troponin T CalSet | ROCHE DIAGNOSTICS GMBH | |
24 | 04015630921621 | 4660307190 | 4660307190 | Elecsys Troponin T STAT Assay | ROCHE DIAGNOSTICS GMBH | |
25 | 04015630920938 | 4491815190 | 4491815190 | Elecsys Troponin T | ROCHE DIAGNOSTICS GMBH | |
26 | 04015630901234 | 11937553193 | 11937553193 | Roche CARDIAC Control Troponin T | ROCHE DIAGNOSTICS GMBH | |
27 | 04015630002481 | 11621947196 | 11621947196 | Roche CARDIAC TROP T Sensitive | ROCHE DIAGNOSTICS GMBH | |
28 | 03573026229115 | 30448-01 | VIDAS ® Troponin I Ultra (TNIU) is an automated quantitative test for use on the VIDAS ® Troponin I Ultra (TNIU) is an automated quantitative test for use on the VIDAS instruments for the determination of human cardiac troponin I in human serum or plasma. | VIDAS® TROPONIN I Ultra | BIOMERIEUX SA | |
29 | 00899722002795 | 97022HS | 97022HS | Alere Triage® Cardiac Panel, CK-MB and TnI | Alere Triage® | ALERE SAN DIEGO, INC. |
30 | 00899722002788 | 97021HS | 97021HS | Alere Triage® Cardiac Panel, TnI | Alere Triage® | ALERE SAN DIEGO, INC. |
31 | 00899722002740 | 97300EU | 97300EU | Alere Triage® Profiler SOB™ Panel | Alere Triage® | ALERE SAN DIEGO, INC. |
32 | 00899722002719 | 97000HSEU | 97000HSEU | Alere Triage® Cardiac Panel | Alere Triage® | ALERE SAN DIEGO, INC. |
33 | 00895160002496 | TF3154 | TF3154 | In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin and Creatine kinase MB in human whole blood, serum and plasma | Fluoro-CheckTM AMI 3 in 1 | NANO-DITECH CORPORATION |
34 | 00895160002458 | CD402P | CD402P | In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin, In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin, Creatine kinase MB and Nt-proBNP in human serum and plasma | Nano-CheckTM 4 in 1 Test | NANO-DITECH CORPORATION |
35 | 00895160002137 | CD302P | CD302P | In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin and Creatine kinase MB in human whole blood, serum and plasma | Nano-CheckTM AMI 3 in 1 | NANO-DITECH CORPORATION |
36 | 00895160002120 | CD202P | CD202P | In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I and Myoglob In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I and Myoglobin in human whole blood, serum and plasma | Nano-CheckTM AMI 2 in 1 | NANO-DITECH CORPORATION |
37 | 00895160002113 | CD7140 | CD7140 | In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I in human wh In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I in human whole blood, plasma and serum | Nano-CheckTM AMI cTnI | NANO-DITECH CORPORATION |
38 | 00895160002090 | CD301S | CD301S | In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I, Myoglobin and Creatine kinase MB in human serum and plasma | Nano-CheckTM AMI 3 in 1 | NANO-DITECH CORPORATION |
39 | 00895160002083 | CD201S | CD201S | In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I and Myoglob In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I and Myoglobin in human serum and plasma | Nano-CheckTM AMI 2 in 1 | NANO-DITECH CORPORATION |
40 | 00895160002076 | CD7141 | CD7141 | In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I in human se In Vitro Diagnostic Test kit for the detection of Cardiac Troponin I in human serum and plasma | Nano-CheckTM AMI cTnI | NANO-DITECH CORPORATION |
41 | 00894175000466 | DACD166772-1-19 | 166772-1-19 | OneStep Troponin I RapiCard™ InstaTest (Serum/WB)A collection of reagents and ot OneStep Troponin I RapiCard™ InstaTest (Serum/WB)A collection of reagents and other associated materials intended to be used for the qualitative detection of troponin I in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses. | RapiCard™ InstaTest | DIAGNOSTIC AUTOMATION, INC. |
42 | 00893038002821 | 98600EU | 98600EU | Alere Triage® Troponin I Test | Alere Triage® | ALERE SAN DIEGO, INC. |
43 | 00893038002814 | 97500EU | 97500EU | Alere Triage® Cardio2 Panel | Alere Triage® | ALERE SAN DIEGO, INC. |
44 | 00893038002807 | 97400EU | 97400EU | Alere Triage® Cardio3 Panel | Alere Triage® | ALERE SAN DIEGO, INC. |
45 | 00893038002197 | 97000HS | 97000HS | Alere Triage® Cardiac Panel | Alere Triage® | ALERE SAN DIEGO, INC. |
46 | 00842768037726 | 10471068 | RF627 | LOCI High-Sensitivity Troponin I (TNIH) | Dimension EXL LOCI Troponin I High Sensitive | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
47 | 00842768037719 | 10471067 | K6427 | High-Sensitivity Troponin (TNIH) Dimension Vista - RGT 120T | Dimension Vista Troponin I High Sensitive | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
48 | 00842768022067 | 10464525 | RF621 | Cardiac Troponin I Flex® reagent cartridge, 144 tests | Dimension® EXL™ LOCI® Module Flex® reagent cartridge TNI | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
49 | 00842768015892 | 10445205 | KD692 | CTNI Sample Diluent, 6x2.5mL | Dimension Vista®/Dimension® EXL™ CTNI SDIL | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
50 | 00842768015151 | 10445098 | K6421 | Cardiac Troponin I Flex® reagent cartridge, 120 tests | Dimension Vista® Flex® reagent cartridge CTNI | SIEMENS HEALTHCARE DIAGNOSTICS INC. |