This standard specifies the technical requirements, test methods, labels, instructions for use, packaging, transportation and storage of creatinine determination reagents (kits) (sarcosine oxidase method). This standard applies to creatinine determination reagents (boxes) for quantitative detection of creatinine concentration in serum, plasma, and urine using the sarcosine oxidase method, including manual reagents and reagents used on semi-automatic and fully-automatic biochemical analyzers. This standard does not apply to creatinine determination reagents (boxes) using the picric acid method. This standard does not apply to Thousand-type creatinine determination reagent (box).
YY/T 1231-2014 history
2014YY/T 1231-2014 Creatinine test reagent kit (Method of sarcosine oxidase)