YY/T 0456.1-2003
Replaced
YY/T 1588-2018
Active
Industry standards-Medicine
YY/T 1588-2018 Procalcitonin testing kit
YY/T 1588-2018 Procalcitonin testing kit
Basic Information
Standard Code:
YY/T 1588-2018
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
Laboratory medicine
Publish Date:
2018-02-24
Implement Date:
2019-03-01
Pages:
7 pages
Scope
This standard specifies the requirements for procalcitonin assay kits, test methods, labeling, instructions for use, packaging, transportation, and storage. This standard applies to kits (hereinafter referred to as "kits") that use the principle of antigen-antibody reaction to quantitatively detect procalcitonin in serum or plasma samples. This standard does not apply to immunoassay methods.
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
Related Standards
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