YY/T 1216-2013: Alpha-fetoprotein quantitative labelling immunoassay kit

Delivery: 9 seconds. Download (and Email) true-PDF + Invoice.
Get Quotation: Click YY/T 1216-2013 (Self-service in 1-minute)
Newer / historical versions: YY/T 1216-2013

Preview True-PDF

Scope

This Standard specifies the classification, requirements, test method, marks, labels,
operating instructions, packaging, transportation, and storage of the alpha-fetoprotein
quantitative labelling immunoassay kit.
This Standard is applicable to the quantitative detection of alpha-fetoprotein labelling
immunoassay kit (hereinafter referred to as AFP kit). It includes AFP immunoassay kit of
quantitative detection by using labelling methods such as enzyme labelling, (electrical)
chemiluminescent labelling, (time resolution) fluorescence labelling AS capture antibody;
and using microplates, pipes, magnetic particles, microbeads, plastic beads and others
AS the carrier coated antibody.
This Standard does not apply to.
a) Colloidal gold labelled AFP test strip;
b) Various types of radio-immunity or IRMA reagent kit labelled with 125I and other
radioactive isotopes.

Basic Data

Standard ID	YY/T 1216-2013 (YY/T1216-2013)
Description (Translated English)	Alpha-fetoprotein 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	8,847
Quoted Standard	YY 0466.1
Regulation (derived from)	State Food and Drug Administration announcement 2013 No. 36; industry standard for filing Notice 2013 No. 12 (No. 168 overall)
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies: a quantitative marker alpha-fetoprotein immunoassay kit classification, requirements, test methods, manual, marking, labeling and packaging, transportation and storage. This standard applies to: conduct quantitative determination