| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 14560189212463 | N/A | LCP | Assay, Glycosylated Hemoglobin | ST AIA-PACK HbA1c | |||
| 2 | 14560189212135 | N/A | KHQ | Radioassay, Triiodothyronine Uptake | ST AIA-PACK T-U | |||
| 3 | 14560189212005 | N/A | CGN | Acid, Folic, Radioimmunoassay | AIA-PACK RBC FOLATE | |||
| 4 | 04560189211827 | N/A | CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 | AIA-PACK PRL CALIBRATOR SET | ||
| 5 | 04560189211407 | N/A | CFP | Radioimmunoassay, Immunoreactive Insulin | 1 | AIA-PACK IRI CALIBRATOR SET | ||
| 6 | 04560189211292 | N/A | CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 | AIA-PACK FSH Sample Diluting Solution | ||
| 7 | 04560189212299 | N/A | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | AIA-PACK bHCG Calibration Verification Test Set | ||
| 8 | 04560189212022 | N/A | CGN | Acid, Folic, Radioimmunoassay | 2 | AIA-PACK RBC FOLATE HEMOLYZING REAGENT SET | ||
| 9 | 14560189212739 | N/A | CHP | Radioimmunoassay, Estradiol | ST AIA-PACK hsE2 | |||
| 10 | 14560189212517 | N/A | CKG | Radioimmunoassay, Acth | ST AIA-PACK ACTH | |||
| 11 | 14560189212104 | n/a | LTJ | Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers | ST AIA-PACK PA | |||
| 12 | 14560189211916 | N/A | CGN | Acid, Folic, Radioimmunoassay | AIA-PACK Folate | |||
| 13 | 04560189211940 | N/A | CGN | Acid, Folic, Radioimmunoassay | 2 | AIA-PACK Floate Sample Diluting Solution | ||
| 14 | 14560189211879 | N/A | CDD | Radioassay, Vitamin B12 | AIA-PACK B12 | |||
| 15 | 04560189211889 | N/A | CDD | Radioassay, Vitamin B12 | 2 | AIA-PACK B12 Calibrator Set | ||
| 16 | 04560189211650 | N/A | CEP | Radioimmunoassay, Luteinizing Hormone | 1 | ST AIA-PACK LH II CALIBRATOR SET | ||
| 17 | 04560189211445 | N/A | CFL | Radioimmunoassay, Human Growth Hormone | 1 | AIA-PACK HGH Calibrator Set | ||
| 18 | 04560189211391 | N/A | CFP | Radioimmunoassay, Immunoreactive Insulin | 1 | AIA-PACK IRI SAMPLE DILUTING SOLUTION | ||
| 19 | 04560189211308 | N/A | CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 | AIA-PACK FSH Calibrator Set | ||
| 20 | 14560189210834 | N/A | CFT | Radioimmunoassay, Prolactin (Lactogen) | ST AIA-PACK PRL | |||
| 21 | 14560189210483 | N/A | DBF | Ferritin, Antigen, Antiserum, Control | ST AIA-PACK FER | |||
| 22 | 14560189210391 | N/A | CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | ST AIA-PACK FSH | |||
| 23 | 14560189210360 | N/A | JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 2 | ST AIA-PACK TSH | ||
| 24 | 14560189210285 | N/A | CDP | Radioimmunoassay, Total Triiodothyronine | ST AIA-PACK FT3 | |||
| 25 | 04560189212817 | N/A | LPS | Urinary Homocystine (Nonquantitative) Test System | 2 | ST AIA-PACK Homocysteine Pretreatment Set | ||
| 26 | 04560189212800 | N/A | JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | AIA-PACK Homocysteine Control Set | ||
| 27 | 04560189212596 | N/A | JKC | Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | 1 | ST AIA-PACK DHEA-S Sample Diluting Solution | ||
| 28 | 04560189212190 | N/A | JIT | Calibrator, Secondary | 2 | ST AIA-PACK Cystatin C Calibatator Set | ||
| 29 | 04560189211285 | N/A | CHP | Radioimmunoassay, Estradiol | 1 | ST AIA-PACK E2 CALIBRATOR SET | ||
| 30 | 04560189211278 | N/A | CHP | Radioimmunoassay, Estradiol | 1 | AIA-PACK E2 Sample Diluting Solution | ||
| 31 | 04560189211148 | N/A | LTK | Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) | 2 | AIA-PACK CA 125 Calibrator Set | ||
| 32 | 04560189211124 | N/A | NIG | System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pa System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer | 2 | AIA-PACK CA 19-9 Sample Diluting Solution | ||
| 33 | 04560189211100 | N/A | MOI | System, Test, Immunological, Antigen, Tumor | 2 | AIA-PACK 27.29 Calibrator Set | ||
| 34 | 14560189212173 | N/A | NDY | Test, Cystatin C | ST AIA-PACK Cystatin C | |||
| 35 | 04560189211902 | N/A | CDD | Radioassay, Vitamin B12 | 2 | AIA-PACK B12 Sample Diluting Solution | ||
| 36 | 04560189211780 | N/A | DHX | System, Test, Carcinoembryonic Antigen | 2 | AIA-PACK CEA Sample Diluting Solution | ||
| 37 | 04560189211421 | N/A | JIT | Calibrator, Secondary | 2 | ST AIA-PACK Intact PTH CALIBRATOR SET | ||
| 38 | 04560189211414 | N/A | CEW | Radioimmunoassay, Parathyroid Hormone | 2 | ST AIA-PACK Intact PTH SAMPLE DILUTING SOLUTION | ||
| 39 | 04560189211353 | N/A | JHI | Visual, Pregnancy Hcg, Prescription Use | 2 | AIA-PACK βHCG Calibrator Set | ||
| 40 | 14560189210780 | N/A | DHX | System, Test, Carcinoembryonic Antigen | ST AIA-PACK CEA | |||
| 41 | 14560189213125 | N/A | MRG | System, Test, Vitamin D | ST AIA-PACK 25-OH Vitamin D | |||
| 42 | 14560189210179 | N/A | MOI | System, Test, Immunological, Antigen, Tumor | ST AIA-PACK 27.29 | |||
| 43 | 14560189210155 | N/A | DGC | Ige, Antigen, Antiserum, Control | ST AIA-PACK IgEII | |||
| 44 | 04560189284005 | N/A | KHO | Fluorometer, For Clinical Use | 1 | 9tray Sorter | ||
| 45 | 04560189283992 | AIA-900 | KHO | Fluorometer, For Clinical Use | 1 | AUTOMATED ENZYME IMMUNOASSAY ANALYZER AIA-900 | ||
| 46 | 04560189283619 | N/A | LCP | Assay, Glycosylated Hemoglobin | 2 | G8 Variant Elution Buffer HSi No.2 (S) | ||
| 47 | 04560189213395 | N/A | JIT | Calibrator, Secondary | 2 | ST AIA-PACK PROG II CALIBRATOR SET | ||
| 48 | 04560189213371 | N/A | CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 1 | ST AIA-PACK SHBG SAMPLE DILUTING SOLUTION | ||
| 49 | 04560189213333 | N/A | JIT | Calibrator, Secondary | 2 | AIA-PACK C-Peptide II Calibrator Set | ||
| 50 | 04560189213135 | N/A | JIT | Calibrator, Secondary | 2 | ST AIA-PACK 25-OH Vitamin D CALIBRATOR SET |
| 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. |