GB/T 29791.2-2013
ActiveIn vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 2: In vitro diagnostic reagents for professional use
体外诊断医疗器械 制造商提供的信息（标示） 第2部分：专业用体外诊断试剂
Application Summary AI generated
This standard specifies the labeling requirements for in vitro diagnostic reagents intended for professional use, such as those in clinical laboratories or hospitals. It ensures that manufacturers provide essential information like intended purpose, storage conditions, and performance characteristics on product labels. The standard is applied to diagnostic reagents used by healthcare professionals, not for self-testing by patients.
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Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.