This part of YY/T 1304 stipulates the terms and definitions, requirements and test methods, identification, labeling and instruction manuals, packaging, transportation and storage of quantitative reagent (kit) for time-resolved fluoroimmunoassay (hereinafter referred to as kits). This part applies to single-label time-resolved fluoroimmunoassay. This part does not apply to dual-label and multi-label time-resolved fluoroimmunoassay.
Basic Data
Standard ID
YY/T 1304.2-2015 (YY/T1304.2-2015)
Description (Translated English)
Detection system of time-resolved fluoroimmunoassay - Part 2: Quantitative reagent (kit) for time-resolved fluoroimmunoassay
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C44
Classification of International Standard
11.100
Word Count Estimation
8,815
Date of Issue
2015-03-02
Date of Implementation
2016-01-01
Quoted Standard
GB/T 21415
Regulation (derived from)
The State Food and Drug Administration Announcement 2015 No. 8
Issuing agency(ies)
State Food and Drug Administration
Summary
This Standard specifies the time-resolved fluorescence immunoassay quantitative assay reagent (kit) (hereinafter referred to as the kit) terms and definitions, requirements and test methods, marking, labeling and instructions for use, packaging, transport and storage. This section applies to a single mark time-resolved fluorescence immunoassay. This section does not apply to more than double labeling and marking time-resolved fluorescence immunoassay.
