YY/T 1197-2013: Translated English of Chinese Standard. (YYT 1197-2013, YY/T1197-2013, YYT1197-2013): Alanine aminotransferase diagnostic kit (IFCC method) [Tips: BUY here & GET online-reading at GOOGLE. Then, if you need unprotected-PDF for offline-reading, WRITE to Wayne: Sales@ChineseStandard.net]
https://www.chinesestandard.net, 4 mars 2015 - 10 pages
This standard specifies the determination principle, requirements, test method, signs, instructions, packaging, transport and storage, etc. of alanine aminotransferase diagnostic kit (IFCC method). This standard applies to the quality control of alanine aminotransferase diagnostic kit (IFCC method). This product is used for in-vitro quantitative determination of the alanine aminotransferase activity in human serum or plasma.
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Mark Label and Instructions
Packaging Transport and Storage
absorbance A2 Absorbance of reagent according to Formula alanine aminotransferase diagnostic Between-batch precision Calculate the mean Calculate the relative catalysis certified reference material coefficient of variation comparison method concentration n units concentration of human concentration of sample correlation coefficient determine the same-batch diagnostic kit IFCC diluted concentration xi End-point method Dilute Expiry date expiry of validity following contents GB/T high and low-value human serum sample IFCC method limit of linear linear interval linear regression low-value quality control manufacturer Marking for Handling mean value measured concentration measured results yi measured value meet the requirements NADH number of medical Product name Production batch number pyruvic acid quality control material reagent blank absorbance reagents kits recovery rate relative deviation Repeat the determination Repeat the test requirements of 4.1 results shall meet serum whose value single kit packaging specified storage condition standard deviation standard solution test method test results Test the reagent Within-batch precision