Standard Number: YY/T 1677-2019(YY/T1677-2019)
Chinese:维生素B12测定试剂盒（标记免疫分析法）
English:Vitamin B12 testing kit（Labelling immunoassay）
Effective Date:2020-10-01
ICS:11.100
Standard Applicability:This standard specifies the requirements, test methods, marking, labeling, instructions for use, packaging, transportation and storage of human vitamin B12 quantitative labeling immunoassay kit. This standard applies to in vitro quantitative detection of human serum or plasma vitamin B12 content of immunoassay kit. This standard does not apply to reagents labeled with colloidal gold or other methods for the qualitative or semi-quantitative determination of human vitamin B12 (e.g., test strips, biochips, etc.); to be used for vitamin B12 calibrators and vitamin B12 quality control products sold separately.
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