GB/T 26124-2011 Active National standards

GB/T 26124-2011 In vitro diagnostic reagent(kit) for clinical chemistry

Publish Date: 2011-05-12 Implement Date: 2011-11-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 26124-2011

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Laboratory medicine

Publish Date: 2011-05-12

Implement Date: 2011-11-01

Pages: 15 pages

Scope

This standard specifies the general technical requirements for the quality inspection of in vitro diagnostic reagents (kits) for clinical chemistry (hereinafter referred to as "reagents (kits)"), including terms and definitions, classification and naming, requirements, test methods, labels and instructions for use, packaging, transportation, and storage.
This standard applies to in vitro diagnostic reagents (kits) based on the principle of spectrophotometry used in medical laboratories for quantitative testing of clinical chemistry projects.
This standard does not apply to:
a) Performance evaluation reagents (such as reagents for research use only);
b) POCT (point-of-care rapid testing) clinical chemistry in vitro diagnostic reagents.