GB/T 29791.4-2013
ActiveIn vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for selftesting
体外诊断医疗器械 制造商提供的信息（标示） 第4部分：自测用体外诊断试剂
Application Summary AI generated
This standard specifies the labeling requirements for in vitro diagnostic reagents intended for self-testing by laypersons, covering information such as intended use, storage conditions, and result interpretation. It is applied to products like home pregnancy tests, blood glucose test strips, and other self-use diagnostic kits sold directly to consumers. The standard ensures that non-professional users receive clear, accurate, and safety-critical instructions to perform tests correctly and understand results without medical training.
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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.