Device typeCreatine kinase myocardial isoenzyme (CKMB) IVD, kit, rapid ICT, clinical: A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of creatine kinase myocardial isoenzyme (CKMB) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
FDA categoryChromatographic Separation, Cpk Isoenzymes, Immunoassay Method, Troponin Subunit, Myoglobin, Fitc, Antigen, Antiserum, Control
Device ID10743816001331
Catalog numberLSC-300-20-02
Single useYes
MRI safetyLabeling does not contain MRI Safety Information