YY 1727-2020 Active Industry standards-Medicine

YY 1727-2020 Human immunodeficiency virus antibodies in human oral mucosal transudate detecting kits (Colloidal gold immuno-chromatography)

Publish Date: 2020-06-30 Implement Date: 2022-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY 1727-2020

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Surgical instruments and materials

Publish Date: 2020-06-30

Implement Date: 2022-06-01

Pages: 8 pages

Scope

This standard specifies the requirements, test methods, labels and user manuals, packaging, transportation, and storage for oral mucosal transudate (OMT) human immunodeficiency virus (HIV) antibody detection kits (colloidal gold immunoassay method).
This standard applies to HIV antibody detection kits (hereinafter referred to as "kits") that use the colloidal gold immunoassay method to qualitatively detect human immunodeficiency virus type 1 and type 2 (HIV-1/2) antibodies in oral mucosal transudate from humans.