This Standard specifies the terms and definitions, requirements, test methods, inspection and judgment, marking, label, instruction manual, packaging, transportation and storage of cardiac troponin I diagnostic kit (colloid gold method). This Standard is applicable to the cardiac troponin I diagnostic kit (colloid gold method). This reagent is used to qualitatively detect the cardiac troponin I (cTnI) in human serum or plasma.
Basic Data
Standard ID
YY/T 1221-2013 (YY/T1221-2013)
Description (Translated English)
Cardiac Troponin I (cTnI) 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
9,993
Quoted Standard
GB/T 191
Regulation (derived from)
State Food and Drug Administration announcement 2013 No. 36; industry standard for filing Notice 2013 No. 12 (No. 168 overall)
Issuing agency(ies)
State Food and Drug Administration
Summary
This standard specifies the diagnostic reagent cardiac troponin I (box) (Colloidal Gold) terms and definitions, requirements, test methods, inspection and judgment, marking, labeling and instructions for use, packaging, transport and storage. This standar
