DZ/T 0101.12-1994
Active
YY/T 1963-2025
Pending
Industry standards-Medicine
YY/T 1963-2025 Colorectal cancer related gene methylation detection kit(Fluorescent PCR )
YY/T 1963-2025 Colorectal cancer related gene methylation detection kit(Fluorescent PCR )
Basic Information
Standard Code:
YY/T 1963-2025
Standard Type:
Industry standards
Standard Status:
Pending
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
-
Publish Date:
2025-06-18
Implement Date:
2026-07-01
Pages:
12 pages
Scope
This document specifies the requirements for methylation detection kits related to colorectal cancer, including labels, user manuals, packaging, transportation, and storage, and describes the corresponding testing methods.
This document is applicable to qualitatively detecting the methylation status of colorectal cancer-related genes in peripheral blood plasma and fecal samples, such as Septin9, SDC2, BCAT1, SFRP2, TFPI2, NDRG4, and BMP3.
This document is applicable to kits using methods such as fluorescence PCR and PCR fluorescence probe methods, but not to kits using high-throughput sequencing methods.
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 191-2025 Graphical symbols marking for handling and storage of packages
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
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