Types of In Vitro Diagnostics: Clearing Up the Confusion

Posted 16 January 2015 By Heidi Hancock Strunk, RAC

placeholder+image In vitro diagnostics: It is easy to get lost in a seemingly foreign language of acronyms for IVDs—ASRs, RUOs, LDTs and more. Can a company explain the differences between ASRs and LDTs—not to mention RUOs, IUOs, “home brew” tests and companion IVD diagnostics? An overview of the various types of IVDs.

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Categories: In vitro diagnostics, Features, US, FDA

Tags: FDA, in vitro medical devices, IVDs, FDA guidance, GPRs, CLIA

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