E-mail In vitro diagnostic devices that are exempt from the IDE requirements of Part 812 must be labeled "For Investigational Use Only. The performance characteristics of this product have not been established."
In vitro diagnostic devices intended for research use (i.e., research IVDs) are devices in the laboratory phase of development and may not be used for clinical (i.e., human) diagnostic or prognostic applications. Research IVDs must be labeled "For research use only. Not for use in diagnostic procedures."
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