YY/T 1220-2013: Creatine kinase isoenzyme MB (CK-MB) diagnostic kit (Colloid gold method)

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Scope

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.

Basic Data

Standard ID	YY/T 1220-2013 (YY/T1220-2013)
Description (Translated English)	Creatine kinase isoenzyme MB (CK-MB) diagnostic kit (Colloid gold method)
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C44
Classification of International Standard	11.100
Word Count Estimation	8,862
Quoted Standard	YY/T 0466.1
Regulation (derived from)	State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall)
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the creatine kinase (CK-MB) diagnostic reagent (box) (Colloidal Gold) terms and definitions, requirements, test methods, inspection and judgment, marking, labeling and instructions for use, packaging, transport and storage. This st