YY/T 1233-2014 Active
YY/T 1233-2014 Cardiac troponin-I(cTnI)quantitative detection reagent(kit)(Chemiluminescent immunoassay)
Abstract
This standard specifies the terms and definitions, requirements, test methods, marking, labeling, user manuals, packaging, transportation, and storage for quantitative determination reagents (kits) for myocardial troponin I (cTnI) using chemiluminescence immunoassay.
This standard applies to quantitative determination reagents (kits) for human myocardial troponin I (cTnI) based on the principle of chemiluminescence immunoassay, including enzymatic and non-enzymatic chemiluminescence immunoassay reagents (kits) using microwell plates, tubes, magnetic particles, etc. as carriers.
This standard does not apply to the requirements for calibrators and quality control materials in the reagent kits.
General Product Information
| Document Type | Industry standards-Medicine |
|---|---|
| Standard Status | Active |
| Standard Code | YY/T 1233-2014 |
| CCS | Medical laboratory equipment |
| ICS | Laboratory medicine |
| Implement Date | 2015-07-01 |