YY/T 1233-2014
Cardiac troponin-I(cTnl) quantitative detection reagent (kit) (Chemiluminescent immunoassay) (English Version)
- Standard No.
- YY/T 1233-2014
- Language
- Chinese, Available in English version
- Release Date
- 2014
- Published By
- Professional Standard - Medicine
- Latest
- YY/T 1233-2014
- Scope
- This standard specifies the terms and definitions, requirements, test methods, identification, labels, instructions for use, packaging, transportation and storage of cardiac troponin-I quantitative determination reagents (kits) (chemiluminescence immunoassay). This standard is applicable to the quantitative determination of human cardiac troponin-I (cTnI) based on the principle of chemiluminescence immunoassay reagent (kit) [hereinafter referred to as "cTnI reagent (kit)"], including microwell plates, tubes, Enzymatic and non-enzymatic chemiluminescence immunoassay assay reagents (boxes) using magnetic particles as carriers. This standard does not apply to the requirements for calibrators and quality control materials in kits.
YY/T 1233-2014 history
- 2014 YY/T 1233-2014 Cardiac troponin-I(cTnl) quantitative detection reagent (kit) (Chemiluminescent immunoassay)
