YY/T 0456.1-2003
Replaced
YY/T 1645-2019
Active
Industry standards-Medicine
YY/T 1645-2019 Detection kit for IgG antibody to human parvovirus B19
YY/T 1645-2019 Detection kit for IgG antibody to human parvovirus B19
Basic Information
Standard Code:
YY/T 1645-2019
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
Laboratory medicine
Publish Date:
2019-05-31
Implement Date:
2020-06-01
Pages:
6 pages
Scope
This standard specifies the requirements, testing methods, labels and instructions, packaging, transportation, and storage for the human parvovirus B19 IgG antibody detection kits (hereinafter referred to as "kits").
This standard applies to kits that use enzyme-linked immunosorbent assay (ELISA) and chemiluminescence assay as the detection principle to qualitatively detect human parvovirus B19 IgG antibodies in human serum/plasma.
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 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 191-2025 Graphical symbols marking for handling and storage of packages
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YY/T 0456.2-2003
Replaced
YY/T 0456.2-2003 Regents for hematology analyzer use—Part 2:Hemolysin
YY/T 0456.3-2003
Replaced
YY/T 0456.3-2003 Regents for hematology analyzer use—Part 3:Diluent
YY/T 0475-2004
Replaced
YY/T 0475-2004 General technical requirements for urine analyzer
YY/T 0478-2004
Replaced
YY/T 0478-2004 General technical requirements for chemical reagent strips for urinalysis
YY/T 0032-2004
Active