YY/T 0456.1-2003
Replaced
YY/T 1677-2019
Active
Industry standards-Medicine
YY/T 1677-2019 Vitamin B12 testing kit(labelling immunoassay)
YY/T 1677-2019 Vitamin B12 testing kit(labelling immunoassay)
Basic Information
Standard Code:
YY/T 1677-2019
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
Laboratory medicine
Publish Date:
2019-10-23
Implement Date:
2020-10-01
Pages:
7 pages
Scope
This standard specifies the requirements for quantitative labeling immunoassay kits for human vitamin B12, the test methods, marking, labeling, user manuals, packaging, transportation, and storage.
This standard applies to immunoassay kits used for the quantitative detection of vitamin B12 in human serum or plasma in vitro.
Development Information
Referenced Standards
GB/T 191-2000 Packaging—Pictorial marking for handling of goods
GB/T 191-2008 Packaging—Pictorial marking for handling of goods
GB/T 21415-2008 In vitro diagnostic medical devices—Measurement of quantities in biological samples—Metrological traceability of values assigned to calibrators and control materials
GB/T 29791.2-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer (labelling)—Part 2:In vitro diagnostic reagents for professional use
GB/T 21415-2025 In vitro diagnostic medical devices—Requirements for establishing metrological traceability of values assigned to calibrators,trueness control materials and human samples
GB/T 191-2025 Graphical symbols marking for handling and storage of packages
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