This Standard specifies the general technical requirements for detection reagent (kit) for enzyme-linked immunoabsorbent assay, including terms and definitions, classification, requirements, test methods, labeling, instructions for use, packaging, transportation and storage. This Standard applies to quantitative/qualitative detection reagent (kit) (hereinafter referred to as "reagent kit") for the principle of enzyme-linked immunosorbent assay in medical laboratories.
Basic Data
Standard ID
YY/T 1183-2010 (YY/T1183-2010)
Description (Translated English)
Detection reagent (kit) for enzyme-linked immunoabsorbent assay (ELISA)
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C44
Classification of International Standard
11.100
Word Count Estimation
18,175
Date of Issue
2010-12-27
Date of Implementation
2012-06-01
Quoted Standard
GB/T 21415-2008
Regulation (derived from)
State Food and Drug Administration Notice 2010 No. 97
Issuing agency(ies)
State Food and Drug Administration
Summary
This standard specifies the enzyme-linked immunosorbent assay reagent (box) the general technical requirements. Including terminology and definitions, classification, requirements, test methods, marking and instructions, packaging, transportation and storage. This standard applies to the medical laboratory ELISA test for the principle of quantitative/qualitative detection side reagent (box).
