YY/T 0456.1-2003
Replaced
YY/T 1421-2016
Active
Industry standards-Medicine
YY/T 1421-2016 Apolipoprotein B test reagent
YY/T 1421-2016 Apolipoprotein B test reagent
Basic Information
Standard Code:
YY/T 1421-2016
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
Laboratory medicine
Publish Date:
2016-01-26
Implement Date:
2017-01-01
Pages:
8 pages
Scope
This standard specifies the requirements for apolipoprotein B assay kits, including testing methods, marking, labeling, user manuals, packaging, transportation, and storage.
This standard applies to immunoturbidimetry (transmission method) kits for quantitatively detecting apolipoprotein B in human serum or plasma, including reagents used on manual, semi-automatic, and fully automatic biochemical analyzers.
Development Information
Referenced Standards
YY/T 0466.1-2009 Medical devices—Symbols to be used with medical device labels, labelling and information to be supplied—Part 1:General requirements
YY/T 0466.1-2016 Medical devices—Symbols to be used with medical device labels,labelling and information to be supplied—Part 1:General requirements
YY/T 0466.1-2023 Medical devices—Symbols to be used with information to be supplied by the manufacturer—Part 1:General requirements
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