This Standard specifies the requirements, test methods, label and use instructions, package, transportation and storage of prolactin quantitative labelling immunoassay kit. This Standard is applicable to the prolactin quantitative determining kit based on the principle of double antibody sandwich method. This Standard is not applicable to the prolactin semi-quantitative determining reagent (such as test paper strip, etc.) labelled by colloidal gold or other methods; neither the various prolactin radioimmunoassay or immunoradiometric kits labelled by radioisotopes such as 125I.
Basic Data
Standard ID
YY/T 1516-2017 (YY/T1516-2017)
Description (Translated English)
Prolactin 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
7,745
Date of Issue
2017-03-28
Date of Implementation
2018-04-01
Regulation (derived from)
China Food and Drug Administration Announcement 2017 No. 38
