GB/T 12715-1991
Abolished
GB/T 37871-2019
Active
National standards
GB/T 37871-2019 Technical specification for quality evaluation of nucleic acid test kit
GB/T 37871-2019 Technical specification for quality evaluation of nucleic acid test kit
Basic Information
Standard Code:
GB/T 37871-2019
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Chemical Industry Complex
ICS Name:
Biology, botany, and zoology
Publish Date:
2019-08-30
Implement Date:
2019-08-30
Pages:
7 pages
Scope
This standard specifies the terms and definitions, evaluation requirements, evaluation indicators, and evaluation methods for the quality evaluation of nucleic acid detection kits. This standard applies to nucleic acid detection kit products and services. This standard does not apply to nucleic acid detection kits for high-throughput sequencing.
Development Information
Referenced Standards
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 37868-2019 Technical specification for traceability of nucleic acid test kit
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