No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 30014613338123 | 94614 | 94614 | Triage TOX Drug Screen, 94600 Control 2 | DIF | Drug mixture control materials | 1 | Triage |
2 | 30014613338116 | 94613 | 94613 | Triage TOX Drug Screen, 94600 Control 1 | DIF | Drug mixture control materials | 1 | Triage |
3 | 30014613338109 | 94600 | 94600 | Triage TOX Drug Screen, 94600 | LAF,KHO,DIS,JXM,LFG,LDJ,JXO,DJR,DJG | Gas chromatography, methamphetamine,FLUOROMETER, FOR CLINICAL USE,Enzyme immunoa Gas chromatography, methamphetamine,FLUOROMETER, FOR CLINICAL USE,Enzyme immunoassay, barbiturate,Enzyme immunoassay, benzodiazepine,Radioimmunoassay, tricyclic antidepressant drugs,Enzyme immunoassay, cannabinoids,Enzyme immunoassay, cocaine,Enzyme immunoassay, methadone,Enzyme immunoassay, opiates | 1 | Triage |
4 | 30014613338048 | 98800EU | 98800EU | Triage PLGF Test (OUS) | PZN | Placental growth factor test | Triage | |
5 | 30014613338031 | 98700EU | 98700EU | Triage NT-proBNP Test (OUS) | NBC | TEST,NATRIURETIC PEPTIDE | 2 | Triage |
6 | 30014613338024 | 98600EU | 98600EU | Triage Troponin I Test (OUS) | MMI | IMMUNOASSAY METHOD, TROPONIN SUBUNIT | 2 | Triage |
7 | 30014613338017 | 98100EU | 98100EU | Triage D-Dimer Test (OUS) | DAP | FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL | 2 | Triage |
8 | 30014613338000 | 98100 | 98100 | Triage D-Dimer Test | DAP | FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL | 2 | Triage |
9 | 30014613337997 | 98000XREU | 98000XREU | Triage BNP Test (OUS) | NBC | TEST,NATRIURETIC PEPTIDE | 2 | Triage |
10 | 30014613337980 | 98000XR | 98000XR | Triage BNP Test | NBC | TEST,NATRIURETIC PEPTIDE | 2 | Triage |
11 | 30014613337973 | 97500EU | 97500EU | Triage Cardio2 Panel | NBC,MMI | TEST,NATRIURETIC PEPTIDE,IMMUNOASSAY METHOD, TROPONIN SUBUNIT | 2 | Triage |
12 | 30014613337959 | 97300EU | 97300EU | Triage Profiler SOB Panel (OUS) | DDR,MMI,JHX,NBC,DAP | MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL,IMMUNOASSAY METHOD, TROPONIN SUBUNIT,FLUO MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL,IMMUNOASSAY METHOD, TROPONIN SUBUNIT,FLUOROMETRIC METHOD, CPK OR ISOENZYMES,TEST,NATRIURETIC PEPTIDE,FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL | 2 | Triage |
13 | 30014613337942 | 97022HS | 97022HS | Triage Cardiac Panel (CK/TnI) | MMI,JHX | IMMUNOASSAY METHOD, TROPONIN SUBUNIT,FLUOROMETRIC METHOD, CPK OR ISOENZYMES | 2 | Triage |
14 | 30014613337935 | 97021HS | 97021HS | Triage Cardiac Panel (TnI) | MMI | IMMUNOASSAY METHOD, TROPONIN SUBUNIT | 2 | Triage |
15 | 30014613337928 | 97000HSEU | 97000HSEU | Triage Cardiac Panel (OUS) | DOR,MMI,JHX | RADIOIMMUNOASSAY, DIGOXIN (3-H), BOVINE ANTIBODY, CHARCOAL SEP.,IMMUNOASSAY METH RADIOIMMUNOASSAY, DIGOXIN (3-H), BOVINE ANTIBODY, CHARCOAL SEP.,IMMUNOASSAY METHOD, TROPONIN SUBUNIT,FLUOROMETRIC METHOD, CPK OR ISOENZYMES | 2 | Triage |
16 | 30014613337911 | 97000HS | 97000HS | Triage Cardiac Panel | MMI,JHX,DDR | IMMUNOASSAY METHOD, TROPONIN SUBUNIT,FLUOROMETRIC METHOD, CPK OR ISOENZYMES,MYOG IMMUNOASSAY METHOD, TROPONIN SUBUNIT,FLUOROMETRIC METHOD, CPK OR ISOENZYMES,MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL | 2 | Triage |
17 | 30014613337904 | 94400EU | 94400EU | Triage TOX Drug Screen (OUS) | LAF,LDP,DKZ,DJG,LCM,LDJ,DIS,JXO,MLK,JXM,DJR | Gas chromatography, methamphetamine,COLORIMETRY, ACETAMINOPHEN,Enzyme immunoassa Gas chromatography, methamphetamine,COLORIMETRY, ACETAMINOPHEN,Enzyme immunoassay, amphetamine,Enzyme immunoassay, opiates,Enzyme immunoassay, phencyclidine,Enzyme immunoassay, cannabinoids,Enzyme immunoassay, barbiturate,Enzyme immunoassay, cocaine,Thin layer chroomatography, tricyclic antidepressant drugs,Enzyme immunoassay, benzodiazepine,Enzyme immunoassay, methadone | 2 | Triage |
18 | 30014613337898 | 94404 | 94404 | Triage TOX Drug Screen (7 Panel) | LAF,DKZ,DJG,DIS,JXO,JXM,LDJ | Gas chromatography, methamphetamine,Enzyme immunoassay, amphetamine,Enzyme immun Gas chromatography, methamphetamine,Enzyme immunoassay, amphetamine,Enzyme immunoassay, opiates,Enzyme immunoassay, barbiturate,Enzyme immunoassay, cocaine,Enzyme immunoassay, benzodiazepine,Enzyme immunoassay, cannabinoids | 2 | Triage |
19 | 30014613337881 | 94402 | 94402 | Triage TOX Drug Screen (9 Panel) | DKZ,DJG,LAF,LCM,MLK,JXO,LDJ,DIS,JXM | Enzyme immunoassay, amphetamine,Enzyme immunoassay, opiates,Gas chromatography, Enzyme immunoassay, amphetamine,Enzyme immunoassay, opiates,Gas chromatography, methamphetamine,Enzyme immunoassay, phencyclidine,Thin layer chroomatography, tricyclic antidepressant drugs,Enzyme immunoassay, cocaine,Enzyme immunoassay, cannabinoids,Enzyme immunoassay, barbiturate,Enzyme immunoassay, benzodiazepine | 2 | Triage |
20 | 30014613337874 | 94401 | 94401 | Triage TOX Drug Screen (10 Panel) | MLK,LCM,DKZ,DJR,LAF,DIS,LDJ,JXM,DJG,JXO | Thin layer chroomatography, tricyclic antidepressant drugs,Enzyme immunoassay, p Thin layer chroomatography, tricyclic antidepressant drugs,Enzyme immunoassay, phencyclidine,Enzyme immunoassay, amphetamine,Enzyme immunoassay, methadone,Gas chromatography, methamphetamine,Enzyme immunoassay, barbiturate,Enzyme immunoassay, cannabinoids,Enzyme immunoassay, benzodiazepine,Enzyme immunoassay, opiates,Enzyme immunoassay, cocaine | 2 | Triage |
21 | 30014613337867 | 94400 | 94400 | Triage TOX Drug Screen | LDP,MLK,DKZ,LAF,JXM,LCM,LDJ,DIS,JXO,DJR,DJG | COLORIMETRY, ACETAMINOPHEN,Thin layer chroomatography, tricyclic antidepressant COLORIMETRY, ACETAMINOPHEN,Thin layer chroomatography, tricyclic antidepressant drugs,Enzyme immunoassay, amphetamine,Gas chromatography, methamphetamine,Enzyme immunoassay, benzodiazepine,Enzyme immunoassay, phencyclidine,Enzyme immunoassay, cannabinoids,Enzyme immunoassay, barbiturate,Enzyme immunoassay, cocaine,Enzyme immunoassay, methadone,Enzyme immunoassay, opiates | 2 | Triage |
22 | 30014613337720 | 98202 | 98202 | Triage BNP Calibrators | JIT | Calibrator, secondary | 2 | Triage |
23 | 30014613337713 | 98201 | 98201 | Triage BNP QC Controls | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Triage |
24 | 30014613337706 | 98200 | 98200 | Triage BNP Reagents | NBC | TEST,NATRIURETIC PEPTIDE | 2 | Triage |
25 | 30014613337164 | 55071 | 55071 | Triage MeterPro, International | JHX,KHO,MMI,DDR | FLUOROMETRIC METHOD, CPK OR ISOENZYMES,FLUOROMETER, FOR CLINICAL USE,IMMUNOASSAY FLUOROMETRIC METHOD, CPK OR ISOENZYMES,FLUOROMETER, FOR CLINICAL USE,IMMUNOASSAY METHOD, TROPONIN SUBUNIT,MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL | 1 | Triage |
26 | 30014613337157 | 55070 | 55070 | Triage MeterPro, North America | MMI,JHX,DDR,KHO | IMMUNOASSAY METHOD, TROPONIN SUBUNIT,FLUOROMETRIC METHOD, CPK OR ISOENZYMES,MYOG IMMUNOASSAY METHOD, TROPONIN SUBUNIT,FLUOROMETRIC METHOD, CPK OR ISOENZYMES,MYOGLOBIN, ANTIGEN, ANTISERUM, CONTROL,FLUOROMETER, FOR CLINICAL USE | 1 | Triage |
27 | 30014613337140 | 94414 | 94414 | Quidel Triage TOX Drug Screen Control 2 | DIF | Drug mixture control materials | 1 | Triage |
28 | 30014613337133 | 94413 | 94413 | Quidel Triage TOX Drug Screen Control 1 | DIF | Drug mixture control materials | 1 | Triage |
29 | 30014613337126 | 88755 | 88755 | Quidel Triage Total 5 Calibration Verification | JJY | Multi-analyte controls, all kinds (assayed) | 1 | Triage |
30 | 30014613337119 | 88754 | 88754 | Quidel Triage Total 5 Control 2 | JJY | Multi-analyte controls, all kinds (assayed) | 1 | Triage |
31 | 30014613337102 | 88753 | 88753 | Quidel Triage Total 5 Control 1 | JJY | Multi-analyte controls, all kinds (assayed) | 1 | Triage |
32 | 30014613337096 | 88734 | 88734 | Quidel Triage Total 3 Control 2 | JJY | Multi-analyte controls, all kinds (assayed) | 1 | Triage |
33 | 30014613337089 | 88733 | 88733 | Quidel Triage Total 3 Control 1 | JJY | Multi-analyte controls, all kinds (assayed) | 1 | Triage |
34 | 30014613337072 | 98814EU | 98814EU | Triage PLGF Control 2 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Triage |
35 | 30014613337065 | 98813EU | 98813EU | Triage PLGF Control 1 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Triage |
36 | 30014613337058 | 98714EU | 98714EU | Triage NT-proBNP Control 2 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Triage |
37 | 30014613337041 | 98713EU | 98713EU | Triage NT-proBNP Control 1 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Triage |
38 | 30014613337034 | 98015XR | 98015XR | Quidel Triage® BNP Calibration Verification | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Triage |
39 | 30014613337027 | 98014XR | 98014XR | Quidel Triage® BNP Control 2 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Triage |
40 | 30014613337010 | 98013XR | 98013XR | Triage BNP Control 1 | JJX | Single (specified) analyte controls (assayed and unassayed) | 1 | Triage |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 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. | |
2 | 07613336191576 | 09315276160 | 09315276160 | proBNP G2 STAT Elecsys cobas e 100 V2.1 | Elecsys proBNP II STAT Immunoassay | ROCHE DIAGNOSTICS GMBH |
3 | 07613336191569 | 09315268160 | 09315268160 | proBNP G2 Elecsys cobas e 100 V2.1 | Elecsys proBNP II Immunoassay | ROCHE DIAGNOSTICS GMBH |
4 | 07613336191521 | 09315284190 | 09315284190 | proBNP G2 Elecsys E2G 300 V2.1 | Elecsys proBNP II Immunoassay | ROCHE DIAGNOSTICS GMBH |
5 | 07613336158982 | 08469890160 | 08469890160 | Elecsys Troponin T Gen 5 | ROCHE DIAGNOSTICS GMBH | |
6 | 07613336158951 | 08469865160 | 08469865160 | Troponin T G5 STAT Elecsys cobas e100 V2 (E1G) | Elecsys Troponin T Gen 5 | ROCHE DIAGNOSTICS GMBH |
7 | 07613336148273 | 08250472160 | 08250472160 | Elecsys Troponin T Gen 5 | ROCHE DIAGNOSTICS GMBH | |
8 | 04987595301636 | N/A | PATHFAST NTproBNP | LSI MEDIENCE CORPORATION | ||
9 | 04987595301339 | N/A | PATHFAST CK-MB-II | LSI MEDIENCE CORPORATION | ||
10 | 04987595301131 | N/A | PATHFAST cTnI-II | LSI MEDIENCE CORPORATION | ||
11 | 04560189211681 | N/A | AIA-PACK CK-MB Sample Diluting Solution | TOSOH CORPORATION | ||
12 | 04560189211674 | N/A | AIA-PACK CK-MB Calibrator Set | TOSOH CORPORATION | ||
13 | 04560189211049 | N/A | ST AIA-PACK cTnI 2 Sample Dilting Solution | TOSOH CORPORATION | ||
14 | 04015630942695 | 07398000160 | 07398000160 | Elecsys Troponin T Gen 5 STAT | ROCHE DIAGNOSTICS GMBH | |
15 | 04015630939756 | 07027664190 | 07027664190 | Elecsys proBNP II | ROCHE DIAGNOSTICS GMBH | |
16 | 04015630939381 | 5094798160 | 5094798160 | Elecsys Troponin I STAT Immunoassay | ROCHE DIAGNOSTICS GMBH | |
17 | 04015630939374 | 5094810160 | 5094810160 | Elecsys Troponin I Immunoassay | ROCHE DIAGNOSTICS GMBH | |
18 | 04015630939206 | 5390109160 | 5390109160 | Elecsys proBNP II STAT Immunoassay | ROCHE DIAGNOSTICS GMBH | |
19 | 04015630939190 | 4842464160 | 4842464160 | Elecsys Pro BNP II Immunoassay | ROCHE DIAGNOSTICS GMBH | |
20 | 04015630922475 | 4856643190 | 4856643190 | Elecsys Troponin T STAT CalSet | ROCHE DIAGNOSTICS GMBH | |
21 | 04015630922468 | 4856627190 | 4856627190 | Elecsys Troponin T CalSet | ROCHE DIAGNOSTICS GMBH | |
22 | 04015630921621 | 4660307190 | 4660307190 | Elecsys Troponin T STAT Assay | ROCHE DIAGNOSTICS GMBH | |
23 | 04015630920938 | 4491815190 | 4491815190 | Elecsys Troponin T | ROCHE DIAGNOSTICS GMBH | |
24 | 04015630901234 | 11937553193 | 11937553193 | Roche CARDIAC Control Troponin T | ROCHE DIAGNOSTICS GMBH | |
25 | 04015630002481 | 11621947196 | 11621947196 | Roche CARDIAC TROP T Sensitive | ROCHE DIAGNOSTICS GMBH | |
26 | 03573026231453 | 30449-01 | VIDAS ® NT- proBNP is a quantitative test for use on the VIDAS instruments for t VIDAS ® NT- proBNP is a quantitative test for use on the VIDAS instruments for the determination of N terminal fragment of B- type natriuretic peptide in serum/plasma. | VIDAS® NT-proBNP | BIOMERIEUX SA | |
27 | 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 | |
28 | 03573026161613 | 30421-01 | The VIDAS ® Creatine Kinase MB (CKMB) Assay is intended for use on the VIDAS ins The VIDAS ® Creatine Kinase MB (CKMB) Assay is intended for use on the VIDAS instruments for the determination of creatine kinase MB isoenzyme concentration in serum or plasma. | VIDAS® CK-MB | BIOMERIEUX SA | |
29 | 00899722002795 | 97022HS | 97022HS | Alere Triage® Cardiac Panel, CK-MB and TnI | Alere Triage® | ALERE SAN DIEGO, INC. |
30 | 00899722002795 | 97022HS | 97022HS | Alere Triage® Cardiac Panel, CK-MB and TnI | Alere Triage® | ALERE SAN DIEGO, INC. |
31 | 00899722002788 | 97021HS | 97021HS | Alere Triage® Cardiac Panel, TnI | Alere Triage® | ALERE SAN DIEGO, INC. |
32 | 00899722002740 | 97300EU | 97300EU | Alere Triage® Profiler SOB™ Panel | Alere Triage® | ALERE SAN DIEGO, INC. |
33 | 00899722002740 | 97300EU | 97300EU | Alere Triage® Profiler SOB™ Panel | Alere Triage® | ALERE SAN DIEGO, INC. |
34 | 00899722002740 | 97300EU | 97300EU | Alere Triage® Profiler SOB™ Panel | Alere Triage® | ALERE SAN DIEGO, INC. |
35 | 00899722002719 | 97000HSEU | 97000HSEU | Alere Triage® Cardiac Panel | Alere Triage® | ALERE SAN DIEGO, INC. |
36 | 00899722002719 | 97000HSEU | 97000HSEU | Alere Triage® Cardiac Panel | Alere Triage® | ALERE SAN DIEGO, INC. |
37 | 00899722002702 | 98000XREU | 98000XREU | Alere Triage® BNP Test | Alere Triage® | ALERE SAN DIEGO, INC. |
38 | 00899722002177 | 98700EU | 98700EU | Alere Triage® NT-proBNP Test | Alere Triage® | ALERE SAN DIEGO, INC. |
39 | 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 |
40 | 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 |
41 | 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 |
42 | 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 |
43 | 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 |
44 | 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 |
45 | 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 |
46 | 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 |
47 | 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. |
48 | 00893038002821 | 98600EU | 98600EU | Alere Triage® Troponin I Test | Alere Triage® | ALERE SAN DIEGO, INC. |
49 | 00893038002814 | 97500EU | 97500EU | Alere Triage® Cardio2 Panel | Alere Triage® | ALERE SAN DIEGO, INC. |
50 | 00893038002814 | 97500EU | 97500EU | Alere Triage® Cardio2 Panel | Alere Triage® | ALERE SAN DIEGO, INC. |