No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00875197005936 | 07972466190 | 07972466190 | cobas Zika (480 tests) | ||||
2 | 00365702398108 | 5530199160 | 5530199160 | GJS | TEST, TIME, PROTHROMBIN | 2 | CoaguChek XS Pro Kit | |
3 | 00075537180075 | 11379194160 | 11379194160 | KHE | REAGENT, OCCULT BLOOD | 2 | Calibration Strip (Urisys 1100, cobas u 411) | |
4 | 00075537018934 | 11893467160 | 11893467160 | CDM | DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.) | 1 | Chemstrip 5 OB Test Strips | |
5 | 07613336215845 | 08836973160 | 08836973160 | Elecsys HIV Duo | MZF | Test, HIV detection | 2 | Elecsys HIV Duo |
6 | 07613336184615 | 09038078160 | 09038078160 | Vitamin D total G3 Elecsys cobas e 100 | MRG | SYSTEM, TEST, VITAMIN D | 2 | Elecsys Vitamin D total III |
7 | 07613336179512 | 09205683001 | 09205683001 | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | cobas pro transport line | |
8 | 07613336179499 | 09205632001 | 09205632001 | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | cobas pro SSU | |
9 | 07613336172650 | 09038086190 | 09038086190 | Vitamin D total G3 Elecsys E2G 300 | MRG | SYSTEM, TEST, VITAMIN D | 2 | Elecsys Vitamin D total III |
10 | 07613336171677 | 09007784190 | 09007784190 | CDX | Radioimmunoassay, total thyroxine | 2 | Elecsys T4 | |
11 | 07613336171660 | 09007741190 | 09007741190 | CDX | Radioimmunoassay, total thyroxine | 2 | Elecsys T4 | |
12 | 07613336170212 | 08924180160 | 08924180160 | MZF | Test, HIV detection | 2 | Elecsys HIV combi PT | |
13 | 07613336170182 | 08924163160 | 08924163160 | MZF | Test, HIV detection | 2 | Elecsys HIV combi PT | |
14 | 07613336166949 | 08836973190 | 08836973190 | MZF | Test, HIV detection | 2 | Elecsys HIV Duo | |
15 | 07613336164884 | 08764760190 | 08764760190 | CIG | DIAZO COLORIMETRY, BILIRUBIN | 2 | Direct Bilirubin | |
16 | 07613336159804 | 04985354160 | 04985354160 | Anti-HBs CC 3 Elecsys | LOM | Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm) | 3 | Anti-HBs CalCheck |
17 | 07613336158784 | 08463662001 | 08463662001 | JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE | 1 | cobas c 503 analytical unit | |
18 | 07613336155332 | 08372284001 | 08372284001 | NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 2 | Accu-Chek Inform II Base Unit Light | |
19 | 07613336155318 | 08376824190 | 08376824190 | NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 2 | Accu-Chek Inform II Base Unit Light | |
20 | 07613336154403 | 03500373190 | 03500373190 | MTG | Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Ca Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions | 3 | free PSA CalCheck | |
21 | 07613336154373 | 04491734160 | 04491734160 | tPSA reagent 200 | MTF | Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer | 3 | Elecsys tPSA |
22 | 07613336154366 | 04641655160 | 04641655160 | tPSA reagent, 100 Test-Kit | MTF | Total,Prostate Specific Antigen(Noncomplexed&Complexed) For Detection Of Prostate Cancer | 3 | Elecsys tPSA |
23 | 07613336154311 | 06427405160 | 06427405160 | Anti-HCV II 200-Test Kit | MZO | Assay,Enzyme Linked Immunosorbent,Hepatitis C Virus | 2 | Elecsys Anti-HCV II |
24 | 07613336154304 | 06368921160 | 06368921160 | Anti-HCV II 100-Test Kit | MZO | Assay,Enzyme Linked Immunosorbent,Hepatitis C Virus | 2 | Elecsys Anti-HCV II |
25 | 07613336153949 | 04927931161 | 04927931161 | LOM | Test, hepatitis b (b core, be antigen, be antibody, b core igm) | 3 | PreciControl Anti-HBc II | |
26 | 07613336147672 | 08243875190 | 08243875190 | JIT | Calibrator, secondary | 2 | CalSet PTH | |
27 | 07613336141953 | 5920353001 | 5984840001 | NBW | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 2 | Accu-Chek Inform II Base Unit Light | |
28 | 07613336133644 | 08105596190 | 08105596190 | NDY | TEST, CYSTATIN C | 2 | Tina-quant Cystatin C Gen.2 | |
29 | 07613336133583 | 08105529190 | 08105529190 | JZG | System, test, beta-2-microglobulin immunological | 2 | Tinaquant ß2Microglobulin | |
30 | 07613336133521 | 08105448190 | 08105448190 | DER | ALPHA-1-LIPOPROTEIN, ANTIGEN, ANTISERUM, CONTROL | 2 | Tina-quant Apolipoprotein A-1 ver.2 | |
31 | 07613336130230 | 08101396190 | 08101396190 | DEM | ALPHA-1-ANTITRYPSIN, ANTIGEN, ANTISERUM, CONTROL | 2 | Tina-quant a1-Antitrypsin ver.2 | |
32 | 07613336121429 | 08058024190 | 08058024190 | JIF | ENZYMATIC METHOD, AMMONIA | 1 | Ammonia II | |
33 | 07613336121351 | 08057940190 | 08057940190 | KHP | ACID, LACTIC, ENZYMATIC METHOD | 1 | Lactate Gen.2 | |
34 | 07613336121238 | 08057648190 | 08057648190 | DBF | FERRITIN, ANTIGEN, ANTISERUM, CONTROL | 2 | Tina-quant Ferritin Gen.4 | |
35 | 07613336121108 | 08057435190 | 08057435190 | KLT | ENZYME IMMUNOASSAY, CARBAMAZEPINE | 2 | ONLINE TDM Carbamazepine Gen.4 | |
36 | 07613336121061 | 08056951190 | 08056951190 | CIG | DIAZO COLORIMETRY, BILIRUBIN | 2 | Bilirubin Direct Gen.2 | |
37 | 04015630999477 | 5133181160 | 5133181160 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Elecsys Anti-CCP CalCheck | |
38 | 04015630995318 | 11776827160 | 11776827160 | JIX | CALIBRATOR, MULTI-ANALYTE MIXTURE | 2 | Elecsys CalCheck FSH | |
39 | 04015630999200 | 4357221190 | 4357221190 | DLJ | CALIBRATORS, DRUG SPECIFIC | 2 | Total MPA Calibrators | |
40 | 04015630999149 | 4924495190 | 4924495190 | CIG | DIAZO COLORIMETRY, BILIRUBIN | 2 | Direct Bilirubin | |
41 | 04015630997954 | 4642465190 | 4642465190 | LEG | ENZYME IMMUNOASSAY, VALPROIC ACID | 2 | Valproic Acid ONLINE TDM Valproic Acid | |
42 | 04015630997756 | 4490894190 | 4490894190 | DJG | ENZYME IMMUNOASSAY, OPIATES | 2 | Opiates II | |
43 | 04015630996575 | 3304680190 | 3304680190 | DKB | CALIBRATORS, DRUG MIXTURE | 2 | Preciset DAT Plus II | |
44 | 04015630995202 | 11776614190 | 11776614190 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | AFP CalCheck | |
45 | 04015630994847 | 11815601216 | 11815601216 | LGI | FLUORESCENCE POLARIZATION IMMUNOASSAY, CARBAMAZEPINE | 2 | CEDIA Carbamazepine II | |
46 | 04015630994533 | 20766356122 | 20766356122 | DKB | CALIBRATORS, DRUG MIXTURE | 2 | LSD CalibrationControl Pack | |
47 | 04015630993468 | 20737976122 | 20737976122 | DIS | ENZYME IMMUNOASSAY, BARBITURATE | 2 | Abuscreen OnLine Barbiturates | |
48 | 04015630993284 | 11986082216 | 11986082216 | DJG | ENZYME IMMUNOASSAY, OPIATES | 2 | Opiates II | |
49 | 04015630991853 | 11876899216 | 11876899216 | CFR | HEXOKINASE, GLUCOSE | 2 | Glucoquant GlucoseHK | |
50 | 04015630991778 | 11868152190 | 11868152190 | DML | NAD-NADH, SPECIFIC REAGENT FOR ALCOHOL ENZYME METHOD | 2 | Ethyl Alcohol ETH |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 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. |
2 | 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. |
3 | 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. |
4 | 14560189210117 | N/A | ST AIA-PACK cTnI 2 | TOSOH CORPORATION | ||
5 | 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. | |
6 | 10796918001792 | 05-8572 | INSTANT-VIEW Troponin I Serum Cassette Test | INSTANT-VIEW Troponin I Serum Cassette Test | ALFA SCIENTIFIC DESIGNS, INC. | |
7 | 10758750002504 | 6802301 | 6802301 | VITROS Immunodiagnostic Products Troponin I ES Reagent Pack | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. |
8 | 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 |
9 | 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 |
10 | 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 |
11 | 10743816001294 | LSC-210-20-00 | LSC-210-20-00 | LifeSign® MI Myo/TnI; 20 Test kit | LifeSign® MI Myo/TnI card | PRINCETON BIOMEDITECH CORPORATION |
12 | 10743816001263 | LSC-131-20-00 | LSC-131-20-00 | StatusFirst™ Tn I; Quantitative; 20 Test kit; CE | StatusFirst™ Tn I card | PRINCETON BIOMEDITECH CORPORATION |
13 | 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 |
14 | 10743816001249 | LSC-130-20-00 | LSC-130-20-00 | LifeSign® MI Troponin I; 20 Test kit | LifeSign® MI Troponin I card | PRINCETON BIOMEDITECH CORPORATION |
15 | 10054749001986 | 06P23-25 | 06P23-25 | CARTRIDGE, cTnI | i-STAT | ABBOTT POINT OF CARE INC. |
16 | 10054749000187 | 03P90-25 | 03P90-25 | TROPONIN CARTRIDGE | i-STAT | ABBOTT POINT OF CARE INC. |
17 | 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. | |
18 | 07613336158982 | 08469890160 | 08469890160 | Elecsys Troponin T Gen 5 | ROCHE DIAGNOSTICS GMBH | |
19 | 07613336158951 | 08469865160 | 08469865160 | Troponin T G5 STAT Elecsys cobas e100 V2 (E1G) | Elecsys Troponin T Gen 5 | ROCHE DIAGNOSTICS GMBH |
20 | 07613336148273 | 08250472160 | 08250472160 | Elecsys Troponin T Gen 5 | ROCHE DIAGNOSTICS GMBH | |
21 | 04987595301131 | N/A | PATHFAST cTnI-II | LSI MEDIENCE CORPORATION | ||
22 | 04560189211049 | N/A | ST AIA-PACK cTnI 2 Sample Dilting Solution | TOSOH CORPORATION | ||
23 | 04015630942695 | 07398000160 | 07398000160 | Elecsys Troponin T Gen 5 STAT | ROCHE DIAGNOSTICS GMBH | |
24 | 04015630939381 | 5094798160 | 5094798160 | Elecsys Troponin I STAT Immunoassay | ROCHE DIAGNOSTICS GMBH | |
25 | 04015630939374 | 5094810160 | 5094810160 | Elecsys Troponin I Immunoassay | ROCHE DIAGNOSTICS GMBH | |
26 | 04015630922475 | 4856643190 | 4856643190 | Elecsys Troponin T STAT CalSet | ROCHE DIAGNOSTICS GMBH | |
27 | 04015630922468 | 4856627190 | 4856627190 | Elecsys Troponin T CalSet | ROCHE DIAGNOSTICS GMBH | |
28 | 04015630921621 | 4660307190 | 4660307190 | Elecsys Troponin T STAT Assay | ROCHE DIAGNOSTICS GMBH | |
29 | 04015630920938 | 4491815190 | 4491815190 | Elecsys Troponin T | ROCHE DIAGNOSTICS GMBH | |
30 | 04015630901234 | 11937553193 | 11937553193 | Roche CARDIAC Control Troponin T | ROCHE DIAGNOSTICS GMBH | |
31 | 04015630002481 | 11621947196 | 11621947196 | Roche CARDIAC TROP T Sensitive | ROCHE DIAGNOSTICS GMBH | |
32 | 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 | |
33 | 00899722002795 | 97022HS | 97022HS | Alere Triage® Cardiac Panel, CK-MB and TnI | Alere Triage® | ALERE SAN DIEGO, INC. |
34 | 00899722002788 | 97021HS | 97021HS | Alere Triage® Cardiac Panel, TnI | Alere Triage® | ALERE SAN DIEGO, INC. |
35 | 00899722002740 | 97300EU | 97300EU | Alere Triage® Profiler SOB™ Panel | Alere Triage® | ALERE SAN DIEGO, INC. |
36 | 00899722002719 | 97000HSEU | 97000HSEU | Alere Triage® Cardiac Panel | Alere Triage® | ALERE SAN DIEGO, INC. |
37 | 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 |
38 | 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 |
39 | 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 |
40 | 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 |
41 | 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 |
42 | 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 |
43 | 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 |
44 | 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 |
45 | 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. |
46 | 00893038002821 | 98600EU | 98600EU | Alere Triage® Troponin I Test | Alere Triage® | ALERE SAN DIEGO, INC. |
47 | 00893038002814 | 97500EU | 97500EU | Alere Triage® Cardio2 Panel | Alere Triage® | ALERE SAN DIEGO, INC. |
48 | 00893038002807 | 97400EU | 97400EU | Alere Triage® Cardio3 Panel | Alere Triage® | ALERE SAN DIEGO, INC. |
49 | 00893038002197 | 97000HS | 97000HS | Alere Triage® Cardiac Panel | Alere Triage® | ALERE SAN DIEGO, INC. |
50 | 00842768037726 | 10471068 | RF627 | LOCI High-Sensitivity Troponin I (TNIH) | Dimension EXL LOCI Troponin I High Sensitive | SIEMENS HEALTHCARE DIAGNOSTICS INC. |