YY/T 0456.1-2003
Replaced
YY/T 1826-2021
Active
Industry standards-Medicine
YY/T 1826-2021 Group B streptococcus nucleic acid detection kit (fluorescent PCR)
YY/T 1826-2021 Group B streptococcus nucleic acid detection kit (fluorescent PCR)
Basic Information
Standard Code:
YY/T 1826-2021
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
Laboratory medicine
Publish Date:
2021-12-06
Implement Date:
2022-12-01
Pages:
9 pages
Scope
This document specifies the requirements, testing methods, labels, and user manuals, packaging, transportation, and storage for the Group B Streptococcus nucleic acid detection kit.
This document is applicable to diagnostic kits that use the principle of fluorescence PCR to qualitatively detect Group B Streptococcus nucleic acid in specific areas of newborns or in vaginal and rectal secretions and their cultures of women.
Development Information
Referenced Standards
GB/T 29791.1-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer(labelling)—Part 1:Terms,definitions and general requirements
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
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