T/ZZB 3418-2023 Active Group standards

T/ZZB 3418-2023 Human Papillomavirus (HPV) Nucleic Acid (Type) Detection Kit

T/ZZB 3418-2023 Human Papillomavirus (HPV) Nucleic Acid (Type) Detection Kit

Publish Date: 2023-11-15 Implement Date: 2023-11-25 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us
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Basic Information

Standard Code: T/ZZB 3418-2023
Standard Type: Group standards
Standard Status: Active
is_force_gb: no
CCS Name: Medical laboratory equipment
ICS Name: Laboratory medicine
Publish Date: 2023-11-15
Implement Date: 2023-11-25
Pages: 15 pages

Scope

Main technical content: This document specifies the terms and definitions, basic requirements, technical requirements, testing methods, inspection rules, marking, packaging, transportation, storage, and quality commitments for human papillomavirus (HPV) nucleic acid (typing) detection kits. This document is applicable to human papillomavirus (HPV) nucleic acid (typing) detection kits (hereinafter referred to as "kits") intended for auxiliary diagnosis of HPV infection and/or cervical cancer screening; applicable detection methods include PCR fluorescence method, fluorescence PCR melting curve method, PCR-reverse hybridization method, hybridization capture-chemiluminescence method, enzyme cleavage signal amplification method, gene chip method, PCR capillary electrophoresis fragment analysis method, high-throughput sequencing, etc.

Development Information

Pages: 15 pages

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