This Standard specifies the requirements, test methods, marking, labeling, instructions manual, packaging, transportation, and storage of rubella IgG / IgM antibody detection kit (hereinafter referred to as "reagents (kit)"). This Standard applies to the qualitative detection of rubella IgG / IgM antibody in human serum/plasma detection kit (enzyme-linked immunosorbent assay method), rubella IgG / IgM antibody detection kit (chemiluminescence method), rubella IgG / IgM antibody detection kit (immunofluorescence method), rubella IgG / IgM antibody detection kit (Immunoblotting method), etc.
Basic Data
Standard ID
YY/T 1235-2014 (YY/T1235-2014)
Description (Translated English)
Rubella virus IgG / IgM antibody detection kit
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C44
Classification of International Standard
11.100
Word Count Estimation
8,827
Date of Issue
6/17/2014
Date of Implementation
7/1/2015
Quoted Standard
YY/T 0466.1
Regulation (derived from)
China Food and Drug Administration in 2014 Bulletin No. 30
Issuing agency(ies)
State Food and Drug Administration
Summary
This Standard applies to the qualitative detection of human serum/plasma rubella virus IgG/IgM antibody detection reagent (box) (enzyme-linked immunosorbent assay), rubella virus IgG/IgM antibody detection reagent (box) (chemiluminescence), rubella virus
