This standard specifies the technical requirements, test method, labeling, instructions for use, packaging, transport and storage of creatinine test reagent (kit) (method of sarcosine oxidase). This standard applies to the creatinine test reagent (kit) that is used to carry out quantitative determination of the creatinine concentration in serum, plasma and urine with the method of sarcosine oxidase. It includes manual reagent and reagents used in semi-automatic and full-automatic biochemical analyzer. This standard does not apply to the creatinine test reagent (kit) with picric acid method. This standard does not apply to the dry creatinine test reagent (kit).5.1 General Requirements The marking, labeling and instructions for use shall meet the following requirements: a) The format and contents of the marking, labeling and instructions for use shall be suitable for the intended use of the reagentanbsp;...
|Title||:||YY/T 1231-2014: Translated English PDF of Chinese Standard YY/T1231-2014|
|Publisher||:||www.ChineseStandard.net - 2015-03-04|