YY/T 1182-2010
Nucleic acids amplification test reagents(kits) (English Version)
- Standard No.
- YY/T 1182-2010
- Language
- Chinese, Available in English version
- Release Date
- 2010
- Published By
- Professional Standard - Medicine
- Status
- 2021-01
- Replace By
- YY/T 1182-2020
- Latest
- YY/T 1182-2020
- Scope
- This standard specifies the terms and definitions, naming and classification, technical requirements, test methods, identification, 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). The nucleic acid amplification detection reagent (kit) should include nucleic acid extraction, nucleic acid amplification and product analysis reagent components. If the nucleic acid amplification detection reagent (box) does not contain nucleic acid extraction components, the manufacturer should explain or specify the extraction reagent ( box). This standard does not apply to genotyping, gene chips, virus genotyping/mutation detection reagents (kits) and blood source screening reagents (kits).
YY/T 1182-2010 history
- 2020 YY/T 1182-2020 Nucleic acid amplification detection reagents (box)
- 2010 YY/T 1182-2010 Nucleic acids amplification test reagents(kits)
