ISO 18113-2:2022

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ISO 18113-2:2022 is an international standard focusing on the information supplied by the manufacturer for in vitro diagnostic (IVD) reagents used by professionals. Specifically, it outlines the requirements for labeling, instructions for use, and accessories for IVD reagents, calibrators, and controls designed for professional use. This standard ensures clear and comprehensive information is provided to users, facilitating safe and effective use of these diagnostic tools.