YY/T 1216-2013 Replaced Industry standards-Medicine

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

Publish Date: 2013-10-21 Implement Date: 2014-10-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1216-2013

Standard Type: Industry standards

Standard Status: Replaced

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Laboratory medicine

Publish Date: 2013-10-21

Implement Date: 2014-10-01

Pages: 7 pages

Scope

This standard specifies the classification, requirements, testing methods, user manuals, markings, labels, and packaging, transportation, and storage of quantitative marking immunoassay kits for alpha-fetoprotein (AFP).
This standard applies to marking immunoassay kits (hereinafter referred to as AFP kits) used for quantitative determination of AFP. These kits include those using enzyme marking, chemiluminescence marking, time-resolved fluorescence marking, etc. as capture antibodies, and microplates, tubes, magnetic particles, microbeads, and plastic beads as carriers for antibody coating, for quantitative determination of AFP.
This standard does not apply to:
a) Colloidal gold-marked AFP test strips;
b) Various radioimmunoassay or immunoradiometric kits labeled with radioactive isotopes such as 125I.