This Standard specifies the terms and definitions, requirements, test methods, inspection and judgment, marking, label, instruction manual, packaging, transportation and storage of the creatine kinase isoenzyme MB (CK-MB) diagnostic kit (colloid gold method). This Standard is applicable to the creatine kinase isoenzyme MB (CK-MB) diagnostic kit (colloid 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.