This standard specifies the terms and definitions, requirements, test methods, inspection and judgment, identification, labeling and instructions for use, packaging, transportation and Storage. This standard applies to creatine kinase isoenzyme (CK-MB) diagnostic reagent (box) (colloidal gold method). This reagent is used to qualitatively detect the activity of creatine kinase isoenzyme MB (CK-MB) in human serum or plasma in vitro.
YY/T 1220-2013 Referenced Document
YY/T 0466.1 Symbols for medical devices used for information provided by manufacturers Part 1: General requirements*, 2023-09-05 Update