YY/T 1611-2018 Active Industry standards-Medicine

YY/T 1611-2018 Human immunodeficiency virus antibodies detection kits(Immuno-chromatography)

Publish Date: 2018-12-20 Implement Date: 2020-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1611-2018

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Surgical instruments and materials

Publish Date: 2018-12-20

Implement Date: 2020-01-01

Pages: 7 pages

Scope

This standard specifies the requirements, test methods, marking, labeling, user manuals, packaging, transportation, and storage for human immunodeficiency virus (HIV) antibody detection kits (immunoassay method).
This standard applies to colloidal gold method, colloidal selenium method, immunoassay method, latex assay method, and other human immunodeficiency virus (HIV) antibody detection kits (hereinafter referred to as "kits") that use immunoassay as the principle to perform qualitative detection of HIV type 1 and type 2 (HIV-1/2) antibodies in human serum or plasma.