CDRHNew
Date: May 16, 2016
The following new items were added to the CDRH web pages on May 13, 2016. Previous CDRH New Items can be found on theCDRHNew Page.
- Emergency Use Authorizations: RealStar® Zika Virus RT-PCR Kit U.S. (altona Diagnostics)
- Federal Register: Infectious Disease Next Generation Sequencing Based Diagnostic Devices: Microbial Identification and Detection of Antimicrobial Resistance and Virulence Markers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
- Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act - Guidance for Industry and Food and Drug Administration Staff
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