Standard Number: YY/T 1197-2013(YY/T1197-2013)
Chinese:丙氨酸氨基转移酶(ALT)测定试剂盒(IFCC法)》
English:Alanine aminotransferase diagnostic kit (IFCC method)
Effective Date:2014-10-01
ICS:11.000
Standard Applicability:This standard applies to the quality control of alanine aminotransferase (ALT) assay kit (IFCC method), which is used for in vitro quantitative determination of alanine aminotransferase activity in human serum or plasma. This standard applies to in vitro diagnostic reagents (kits) used in medical laboratories for quantitative testing of alanine aminotransferase (ALT) program. This standard specifies the technical requirements of the kit, including terminology and definitions, classification and naming, requirements, test methods, labeling, instructions for use, packaging, transportation and storage.
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