YY/T 0456.1-2003
Replaced
YY/T 1663-2019
Active
Industry standards-Medicine
YY/T 1663-2019 Progesterone testing kit
YY/T 1663-2019 Progesterone testing kit
Basic Information
Standard Code:
YY/T 1663-2019
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:
7 pages
Scope
This standard specifies the requirements for progesterone assay kits, test methods, labels, user manuals, and packaging, transportation, and storage.
This standard applies to progesterone assay kits (hereinafter referred to as kits), including immunoassay kits for quantitatively measuring progesterone by methods such as enzyme labeling and chemiluminescence labeling.
This standard does not apply to reagents for qualitative or semi-quantitative determination of progesterone labeled with colloidal gold or other methods (such as test strips, biochips, etc.).
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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YY/T 0456.2-2003
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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
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YY/T 0478-2004 General technical requirements for chemical reagent strips for urinalysis
YY/T 0032-2004
Active