This Standard specifies relevant terms and definitions, requirements, test methods, labels and instructions for use, packaging, transportation and storage of diagnostic kit for colloidal gold immunochromatographic assay. This Standard is applicable to diagnostic kit that uses the colloidal gold immunochromatographic assay as the principle to conduct quantitative, semiquantitative, qualitative examinations to human sample (blood, urine, feces, saliva and so on).
Basic Data
Standard ID
YY/T 1713-2020 (YY/T1713-2020)
Description (Translated English)
Diagnostic kit for colloidal gold immunochromatographic assay
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C44
Classification of International Standard
11.100
Word Count Estimation
16,174
Date of Issue
2020-09-27
Date of Implementation
2022-06-01
Regulation (derived from)
Announcement No. 108 (2020) of the National Medical Products Administration
