YY/T 0456.1-2003
Replaced
YY/T 1527-2017
Active
Industry standards-Medicine
YY/T 1527-2017 α/β-Talassemia gene typing detection kit
YY/T 1527-2017 α/β-Talassemia gene typing detection kit
Basic Information
Standard Code:
YY/T 1527-2017
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
Laboratory medicine
Publish Date:
2017-03-28
Implement Date:
2018-04-01
Pages:
6 pages
Scope
This standard specifies the terms and definitions, naming, classification, and composition, requirements, test methods, marking, labeling, and user's manual, packaging, transportation, and storage of the α/β-thalassemia genotyping test kits (hereinafter referred to as "test kits").
This standard applies to the technical methods used in test kits for detecting peripheral whole blood samples and amniotic fluid samples from pregnant women, including real-time PCR fluorescence method, PCR-reverse dot hybridization method, fluorescent PCR melting curve method, gene chip method, gap-PCR method, 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 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
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