This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) reagents, calibrators, and controls intended for self-testing.
This document can also be applicable to accessories.
This document is applicable to the labels for outer and immediate containers and to the instructions for use.
This document does not apply to:
a) IVD instruments or equipment;
b) IVD reagents for professional use.
Status: PublishedPublication date: 2022-10
Edition: 2Number of pages: 11
Technical Committee: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems
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