YY/T 1184-2010 Active Industry standards-Medicine

YY/T 1184-2010 Monoclonal antibody reagent for flow cytometer

Publish Date: 2010-12-27 Implement Date: 2012-06-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1184-2010

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: Laboratory medicine

Publish Date: 2010-12-27

Implement Date: 2012-06-01

Pages: 9 pages

Scope

This standard specifies the general technical requirements for the quality inspection of monoclonal antibody reagents used in flow cytometers. It includes terms and definitions, classification and naming, requirements, test methods, labels and usage instructions, packaging, transportation, and storage.
This standard applies to monoclonal antibody reagents used in flow cytometers by medical laboratories for lymphocyte phenotype analysis of clinical specimens, leukemia/lymphoma typing, or other disease diagnosis and monitoring. These reagents are direct immunofluorescent antibodies (also known as direct-labeled antibodies) and can be used for the detection of cell membrane antigens and intracellular antigens.
The reagents can be a fluorescently labeled direct-labeled antibody or a mixture of two or more direct-labeled antibodies.