This Standard specifies the classification, requirements, inspection methods, labels and instructions for use, packaging, transport and storage for C-peptide quantitative labelling immunoassay kit. This Standard is applicable to C-peptide quantitative labelling immunoassay kit (hereinafter referred to as the kit), including the C-peptide quantitative measuring immunoassay kit in Labeling methods such as enzyme labeling, chemiluminescent labeling, time-resolved fluorescent labeling, etc., using microplates, tubes, magnetic particles, microbeads and plastic beads as carriers.
Basic Data
Standard ID
YY/T 1518-2017 (YY/T1518-2017)
Description (Translated English)
C-peptide quantitative labelling immunoassay kit
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C44
Classification of International Standard
11.100
Word Count Estimation
7,714
Date of Issue
2017-03-28
Date of Implementation
2018-04-01
Regulation (derived from)
China Food and Drug Administration Announcement 2017 No. 38
