T/ZZB 3418-2023 Active
T/ZZB 3418-2023 Human Papillomavirus (HPV) Nucleic Acid (Type) Detection Kit
Abstract
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.
General Product Information
| Document Type | Group standards |
|---|---|
| Standard Status | Active |
| Standard Code | T/ZZB 3418-2023 |
| CCS | Medical laboratory equipment |
| ICS | Laboratory medicine |
| Implement Date | 2023-11-25 |