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Guiding principles and recommendations on labelling of clinical laboratory materials: a WHO memorandum.

Comprehensive labelling forms a vital part of any steps to control the quality of commercially distributed diagnostic reagents. This Memorandum gives recommendations for such labelling. Specifications are given for the recommended minimum information to be given on the label attached to the immediate container of clinical laboratory materials, kits and kit components, reference materials including calibrators and control materials, and where applicable, of general laboratory materials. A package insert or brochure is generally required for clinical laboratory materials, kits, and reference materials, and specifications are also given for information to be given in such inserts or brochures. Definitions of terms used in this Memorandum are given in an Annex. It is hoped that WHO Member States will use these specifications through their adoption as national regulations.