This standard specifies the determination principle, requirements, test method, marks, signs, instructions, packaging, transport and storage of aspartate aminotransferase diagnostic kit (lFCC method). This standard applies to the quality control of aspartate aminotransferase diagnostic kit (lFCC method) This product is used for in-vitro quantitative determination of the aspartate aminotransferase activity in human serum or plasma.
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C44
Classification of International Standard
11.100
Word Count Estimation
10,137
Quoted Standard
YY/T 0466.1; GB/T 191
Regulation (derived from)
State Food and Drug Administration announcement 2013 No. 36; industry standard for filing Notice 2013 No. 12 (No. 168 overall)
Issuing agency(ies)
State Food and Drug Administration
Summary
This standard specifies the aspartate aminotransferase measurement principle enzyme assay kit (IFCC method), requirements, test methods, marking, labeling and instructions for use, packaging, transport and storage of John. This standard applies to asparta
