YY/T 1820-2021 Active Industry standards-Medicine

YY/T 1820-2021 Specific antinuclear antibody IgG detecting kit (immunoblotting)

Publish Date: 2021-12-06 Implement Date: 2023-05-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1820-2021

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Laboratory medicine

Publish Date: 2021-12-06

Implement Date: 2023-05-01

Pages: 7 pages

Scope

This document specifies the requirements, testing methods, marking, labeling, user manuals, packaging, transportation, and storage for the Specific Anti-nuclear Antibody IgG Detection Kit (Immunoblotting Method) (hereinafter referred to as the "kit").
This document applies to kits that use the immunoblotting method to qualitatively detect human serum or plasma anti-nuclear antibodies (ANA) specific to target antigens in the nucleus and cytoplasm, including products that use manual operation and automated instrument operation.
This document does not apply to kits for detecting total ANA.