YY/T 1231-2014 Translated English of Chinese Standard. (YYT 1231-2014, YY/T1231-2014, YYT1231-2014): Creatinine test reagent kit (Method of sarcosine oxidase)https://www.chinesestandard.net, 2015 M03 4 - 14 pages 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). |
Common terms and phrases
0316 are applicable absorbance of reagent according to Formula appropriate words assigned to calibrators batch number Beijing biochemical analyzer biological hazards Calculate the mean Calculate the relative calibrators and control certified reference material coefficient of variation Comparison test component considered dangerous correlation coefficient creatinine test reagent different batches document expiration date external packaging GB/T identified uniquely based Installed capacity interval of 30 labeling and instructions labels of external linear interval linear regression manufacturer Manufacturer's name marking and labels mean value Medical devices meet the requirements method of sarcosine Metrological traceability operation manual packaging shall include packaging to warn radioactive or biological reagent blank reference measurement procedures Repeat the test requirements of 3.7 requirements of YY/T results shall meet sample or quality sarcosine oxidase selected for verification serum sample Shanghai spectrophotometer test results validity period value of measured vitro diagnostic reagent warn the hazards Warning and preventive words or symbols