Standard Number: YY/T 1820-2021(YY/T1820-2021)
Chinese:特异性抗核抗体IgG检测试剂盒(免疫印迹法)
English:Specific antinuclear antibody IgG detecting kit (immunoblotting)
Effective Date:2023-05-01
ICS:11.100.10
Standard Applicability:This standard specifies the requirements, test methods, marking, labeling, instructions for use, packaging, transportation and storage of specific antinuclear antibody IgG detection kit (immunoblotting method) (hereinafter referred to as the kit). This standard applies to the immunoblotting method as the principle of qualitative detection of human serum or plasma against the nucleus and plasma specific target antigen antigen antinuclear antibody specific autoantibody IgG kit, including manual operation and automatic operation of the instrument products. This standard does not apply to kits for the detection of total antinuclear antibodies.
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