YY/T 1184-2010 (English Version) PDF

Scope: This standard specifies the general technical requirements for quality inspection of monoclonal antibody reagents used in flow cytometry. Includes terms and definitions, classification and nomenclature, requirements, test methods, labels and instructions for use, packaging, transportation and storage. This standard applies to monoclonal antibody reagents for flow cytometry used in medical laboratories using flow cytometry to perform lymphocyte phenotype analysis, leukemia/lymphoma classification, or diagnosis and monitoring of other diseases on clinical specimens (hereinafter Reagents) are direct immunolabeled fluorescent antibodies (also known as direct-labeled antibodies) that can be used to detect cell membrane antigens and intracytoplasmic antigens. The reagent can be a fluorescein-labeled directly labeled antibody, or a mixture of two or more directly labeled antibodies.

YY/T 1184-2010 history