FDA.reportPublic FDA data

Multiple cardiac marker IVD, kit, fluorescent immunoassay

Definition
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or a combination of cardiac markers in a clinical specimen, using a fluorescent immunoassay method. Cardiac markers to be assayed may include B-type natriuretic protein, D-dimer, creatine kinase myocardial isoenzyme (CKMB), myoglobin, myeloperoxidase (MPO), fatty acid binding protein (FABP), glycogen phosphorylase isoenzyme BB (GPBB), troponin I and/or troponin T.
GUDID devices
19
Last updated
2023-08-23 07:50:31

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00893038002197Alere Triage®Alere San Diego, Inc.97000HS2016-09-21
00893038002807Alere Triage®Alere San Diego, Inc.97400EU2016-09-26
00893038002814Alere Triage®Alere San Diego, Inc.97500EU2016-09-26
00893038002821Alere Triage®Alere San Diego, Inc.98600EU2016-09-26
00899722002719Alere Triage®Alere San Diego, Inc.97000HSEU2016-09-26
00899722002740Alere Triage®Alere San Diego, Inc.97300EU2016-09-26
00899722002788Alere Triage®Alere San Diego, Inc.97021HS2016-09-21
00899722002795Alere Triage®Alere San Diego, Inc.97022HS2016-09-26
00895160002496Fluoro-CheckTM AMI 3 in 1NANO-DITECH CORPORATIONTF31542019-05-24
30014613337911TriageQUIDEL CARDIOVASCULAR INC.97000HS2018-11-01
30014613337928TriageQUIDEL CARDIOVASCULAR INC.97000HSEU2018-11-01
30014613337935TriageQUIDEL CARDIOVASCULAR INC.97021HS2018-11-01
30014613337942TriageQUIDEL CARDIOVASCULAR INC.97022HS2018-11-01
30014613337959TriageQUIDEL CARDIOVASCULAR INC.97300EU2018-11-01
30014613337966TriageQUIDEL CARDIOVASCULAR INC.97400EU2018-11-01
30014613337973TriageQUIDEL CARDIOVASCULAR INC.97500EU2018-11-01
05391516747783Trinity BiotechMARDX DIAGNOSTICS, INC.10-54482016-09-18
05391516747790Trinity BiotechMARDX DIAGNOSTICS, INC.10-54042016-09-18
05391516747813Trinity BiotechMARDX DIAGNOSTICS, INC.10-54082016-09-18