YY/T 1442-2016 Active Industry standards-Medicine

YY/T 1442-2016 β2—Microglobulin quantitative detection reagents(kit)

Publish Date: 2016-01-26 Implement Date: 2017-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1442-2016

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Laboratory medicine

Publish Date: 2016-01-26

Implement Date: 2017-01-01

Pages: 8 pages

Scope

This standard specifies the requirements, test methods, marking, labeling, user manuals, packaging, transportation, and storage for quantitative detection reagents (kits) of beta-2-microglobulin.
This standard applies to reagents (kits) for quantitative detection of beta-2-microglobulin in blood or urine samples based on the principle of antigen-antibody reaction. The methodology includes quantitative labeled immunoassays and immunoturbidimetry (including immunoturbidimetry and latex-enhanced immunoturbidimetry).
This standard does not apply to the evaluation of beta-2-microglobulin calibrators and quality control products.