This Standard specifies the technical requirements, test methods, label, instruction for use, packaging, transportation and storage of detection kit for IgA antibody to Epstein- barr viral capsid antigens (hereinafter referred to as “detection kit”). This Standard is applicable to detection kit that qualitatively detects IgA antibody to Epstein-Barr viral capsid antigens in human serum/plasma in accordance with the principle of enzyme linked immunosorbent assay, chemiluminescence and time- resolved fluorescence.
Basic Data
Standard ID
YY/T 1517-2017 (YY/T1517-2017)
Description (Translated English)
Detection kit for IgA antibody to epstein-barr viral capsid antigens
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C44
Classification of International Standard
11.100
Word Count Estimation
6,640
Date of Issue
2017-05-02
Date of Implementation
2018-04-01
Regulation (derived from)
China Food and Drug Administration Announcement 2017 No. 49
