YY/T 1182-2010 Replaced Industry standards-Medicine

YY/T 1182-2010 Nucleic acids amplification test reagents(kits)

Publish Date: 2010-12-27 Implement Date: 2012-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1182-2010

Standard Type: Industry standards

Standard Status: Replaced

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Laboratory medicine

Publish Date: 2010-12-27

Implement Date: 2012-06-01

Pages: 11 pages

Scope

This standard specifies the terms and definitions, naming and classification, technical requirements, test methods, marking, labels and instructions, packaging, transportation, and storage of nucleic acid amplification detection reagents (kits) (hereinafter referred to as "reagents (kits)").
This standard applies to the quality control of nucleic acid amplification detection reagents (kits). Nucleic acid amplification detection reagents (kits) should include components for nucleic acid extraction, nucleic acid amplification, and product analysis. If the reagents (kits) do not contain nucleic acid extraction components, the manufacturer should provide an explanation or specify the extraction reagents (kits) to be used.
This standard does not apply to reagents (kits) used for genotyping, gene chips, and virus genotyping/mutation detection, as well as reagents (kits) for blood screening.