Device typeMultiple cardiac marker IVD, kit, fluorescent immunoassay: 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.
FDA categoryFLUOROMETRIC METHOD, CPK OR ISOENZYMES, IMMUNOASSAY METHOD, TROPONIN SUBUNIT, RADIOIMMUNOASSAY, DIGOXIN (3-H), BOVINE ANTIBODY, CHARCOAL SEP.
Device ID30014613337928
Catalog number97000HSEU
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information