| 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 | 00630414986098 | 10642239 | L2KTI2(D) | IMMULITE® 2000 Systems TPI Troponin I | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | |
| 2 | 00630414986081 | 10642238 | LSKTI1(D) | IMMULITE®/IMMULITE® 1000 Systems RTI Turbo Troponin I | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | |
| 3 | 00630414986074 | 10642237 | LKTI1(D) | IMMULITE® 1000 Systems TPI Troponin I | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | |
| 4 | 00630414954394 | 10386995 | LTIZ | Troponin I Sample Diluent - IMMULITE - 1x25mL | IMMULITE®/IMMULITE® 1000 Systems TPI Troponin I Sample Diluent | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
| 5 | 00630414602929 | 10994775 | 10994775 | ADVIA Centaur High Sensitivity Troponin I (TNIH) Assay Kit 500T | ADVIA Centaur TNIH 500T Kit | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 6 | 00630414602912 | 10994774 | 10994774 | ADVIA Centaur High Sensitivity Troponin I (TNIH) Assay Kit 100T | ADVIA Centaur TNIH 100T Kit | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 7 | 00630414600109 | 10995697 | 10995697 | TnI-Ultra Atellica IM - RGT 500T | Atellica IM TnI-Ultra | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 8 | 00630414600093 | 10995696 | 10995696 | TnI-Ultra Atellica IM - RGT 100T | Atellica IM TnI-Ultra | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 9 | 00630414516226 | 10317709 | 2790309 | Troponin I - CENTAUR - RGT - 500 tests | ADVIA Centaur® TnI-Ultra™ | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 10 | 00630414516219 | 10317708 | 2789602 | Troponin I - CENTAUR - RGT - 100 tests | ADVIA Centaur® TnI-Ultra™ | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 11 | 00630414293790 | 11206219 | 11206219 | TnI-Ultra - Atellica IM - RGT 500T | Atellica IM TnI-Ultra | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 12 | 00630414293783 | 11206269 | 11206269 | High Sensitivity Troponin I (TnIH) - Atellica IM - RGT 500T | Atellica IM TNIH | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 13 | 00630414006758 | 10997841 | 10997841 | High Sensitivity Troponin I (TnIH) Atellica IM Assay Kit 500T | Atellica IM TNIH | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 14 | 00630414006703 | 10997840 | 10997840 | High Sensitivity Troponin I (TnIH) Atellica IM Assay Kit 100T | Atellica IM TNIH | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| 15 | 00380740194079 | 04Z2135 | 04Z2135 | Alinity i STAT High Sensitivity Troponin-I Reagent Kit 1200 test | Alinity | ABBOTT IRELAND |
| 16 | 00380740194062 | 04Z2125 | 04Z2125 | Alinity i STAT High Sensitivity Troponin-I Reagent Kit 200 test | Alinity | ABBOTT IRELAND |
| 17 | 00380740175504 | 02R9835 | 02R9835 | ARCHITECT STAT High Sensitivity Troponin-I Reagent Kit 500 Tests | ARCHITECT | ABBOTT IRELAND |
| 18 | 00380740175498 | 02R9825 | 02R9825 | ARCHITECT STAT High Sensitivity Troponin-I Reagent Kit 100 Tests | ARCHITECT | ABBOTT IRELAND |
| 19 | 00380740052836 | 2K41-37 | 02K4137 | ARCHITECT STAT Troponin-I Reagent Kit | ARCHITECT | ABBOTT LABORATORIES |
| 20 | 00380740048525 | 2K41-27 | 02K4127 | ARCHITECT STAT Troponin-I Reagent Kit | ARCHITECT | ABBOTT LABORATORIES |
| 21 | 00380740003180 | 2K41-01 | 02K4101 | ARCHITECT STAT Troponin-I Calibrators | ARCHITECT | ABBOTT LABORATORIES |
| 22 | 00083059070316 | 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. | |
| 23 | B103A25CS30021 | CS3002 | CS3002 | Lateral Flow immunoassay for the qualitative determination of Myoglobin, Troponi Lateral Flow immunoassay for the qualitative determination of Myoglobin, Troponin I, and CK-MB in Human Heparinized Whole Blood, Plasma, or Serum. | Cardiac STATus Myoglobin/Troponin I/CK-MB Tandem Test | INTERNATIONAL POINT OF CARE INCORPORATED |
| 24 | B103A25CS10021 | CS1002 | CS1002 | Lateral Flow immunoassay for the qualitative determination of Troponin I in Huma Lateral Flow immunoassay for the qualitative determination of Troponin I in Human Heparinized Whole Blood, Plasma, or Serum. | Cardiac STATus® TnI | INTERNATIONAL POINT OF CARE INCORPORATED |
| 25 | B103A20CS30021 | CS3002 | CS3002 | Lateral Flow immunoassay for the qualitative determination of Myoglobin, Troponi Lateral Flow immunoassay for the qualitative determination of Myoglobin, Troponin I, and CK-MB in Human Heparinized Whole Blood, Plasma, or Serum. | Cardiac STATus Myoglobin/Troponin I/CK-MB Tandem Test | INTERNATIONAL POINT OF CARE INCORPORATED |
| 26 | B103A20CS10021 | CS1002 | CS1002 | Lateral Flow immunoassay for the qualitative determination of Troponin I in Huma Lateral Flow immunoassay for the qualitative determination of Troponin I in Human Heparinized Whole Blood, Plasma, or Serum. | Cardiac STATus® TnI | INTERNATIONAL POINT OF CARE INCORPORATED |
| 27 | B103A10CS30021 | CS3002 | CS3002 | Lateral Flow immunoassay for the qualitative determination of Myoglobin, Troponi Lateral Flow immunoassay for the qualitative determination of Myoglobin, Troponin I, and CK-MB in Human Heparinized Whole Blood, Plasma, or Serum. | Cardiac STATus Myoglobin/Troponin I/CK-MB Tandem Test | INTERNATIONAL POINT OF CARE INCORPORATED |
| 28 | B103A10CS10021 | CS1002 | CS1002 | Lateral Flow immunoassay for the qualitative determination of Troponin I in Huma Lateral Flow immunoassay for the qualitative determination of Troponin I in Human Heparinized Whole Blood, Plasma, or Serum. | Cardiac STATus® TnI | INTERNATIONAL POINT OF CARE INCORPORATED |
| 29 | 30014613338024 | 98600EU | 98600EU | Triage Troponin I Test (OUS) | Triage | QUIDEL CARDIOVASCULAR INC. |
| 30 | 30014613337973 | 97500EU | 97500EU | Triage Cardio2 Panel | Triage | QUIDEL CARDIOVASCULAR INC. |
| 31 | 30014613337966 | 97400EU | 97400EU | Triage Cardio3 Panel | Triage | QUIDEL CARDIOVASCULAR INC. |
| 32 | 30014613337959 | 97300EU | 97300EU | Triage Profiler SOB Panel (OUS) | Triage | QUIDEL CARDIOVASCULAR INC. |
| 33 | 30014613337942 | 97022HS | 97022HS | Triage Cardiac Panel (CK/TnI) | Triage | QUIDEL CARDIOVASCULAR INC. |
| 34 | 30014613337935 | 97021HS | 97021HS | Triage Cardiac Panel (TnI) | Triage | QUIDEL CARDIOVASCULAR INC. |
| 35 | 30014613337928 | 97000HSEU | 97000HSEU | Triage Cardiac Panel (OUS) | Triage | QUIDEL CARDIOVASCULAR INC. |
| 36 | 30014613337911 | 97000HS | 97000HS | Triage Cardiac Panel | Triage | QUIDEL CARDIOVASCULAR INC. |
| 37 | 30014613337164 | 55071 | 55071 | Triage MeterPro, International | Triage | QUIDEL CARDIOVASCULAR INC. |
| 38 | 30014613337157 | 55070 | 55070 | Triage MeterPro, North America | Triage | QUIDEL CARDIOVASCULAR INC. |
| 39 | 15099590693183 | B52669 | B52699 | Access hsTnI is a paramagnetic particle, chemiluminescent immunoassay for the qu Access hsTnI is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the UniCel DxI Access Immunoassay Systems to aid in the diagnosis of myocardial infarction (MI).Access hsTnI is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of cardiactroponin I (cTnI) levels in human serum and plasma using the Access 2 Immunoassay Systems to aid in the diagnosisof myocardial infarction (MI). | Access hsTnI | BECKMAN COULTER, INC. |
| 40 | 15099590209353 | A98264 | A98264 | The Access AccuTnI+3 Reagent is a paramagnetic particle, chemiluminescent immuno The Access AccuTnI+3 Reagent is a paramagnetic particle, chemiluminescent immunoassay for the highly sensitive quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the UniCel DxI Immunoassay System to aid in the diagnosis of myocardial infarction. | Access AccuTnI+3 | BECKMAN COULTER, INC. |
| 41 | 15099590209322 | A98143 | A98143 | The Access AccuTnI+3 Reagent is a paramagnetic particle, chemiluminescent immuno The Access AccuTnI+3 Reagent is a paramagnetic particle, chemiluminescent immunoassay for the highly sensitive quantitative determination of cardiac troponin I (cTnI) levels in human serum and plasma using the Access 2 Immunoassay System to aid in the diagnosis of myocardial infarction. | Access AccuTnI+3 | BECKMAN COULTER, INC. |
| 42 | 14560189210117 | N/A | ST AIA-PACK cTnI 2 | TOSOH CORPORATION | ||
| 43 | 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. | |
| 44 | 10796918001792 | 05-8572 | INSTANT-VIEW Troponin I Serum Cassette Test | INSTANT-VIEW Troponin I Serum Cassette Test | ALFA SCIENTIFIC DESIGNS, INC. | |
| 45 | 10758750002504 | 6802301 | 6802301 | VITROS Immunodiagnostic Products Troponin I ES Reagent Pack | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
| 46 | 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 |
| 47 | 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 |
| 48 | 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 |
| 49 | 10743816001294 | LSC-210-20-00 | LSC-210-20-00 | LifeSign® MI Myo/TnI; 20 Test kit | LifeSign® MI Myo/TnI card | PRINCETON BIOMEDITECH CORPORATION |
| 50 | 10743816001263 | LSC-131-20-00 | LSC-131-20-00 | StatusFirst™ Tn I; Quantitative; 20 Test kit; CE | StatusFirst™ Tn I card | PRINCETON BIOMEDITECH CORPORATION |