CDRH New Update

CDRHNew

Date: August 18, 2016

The following new items were added to the CDRH web pages on August 17, 2016. Previous CDRH New Items can be found on theCDRHNew Page.

• Emergency Use Authorizations: ZIKV Detect™ IgM Capture ELISA (InBios International, Inc.)
• FDA Recommends Health Care Facilities Stop Using Custom Ultrasonics’ System 83 Plus Automated Endoscope Reprocessors (AERs) for Reprocessing Duodenoscopes; These Reprocessors Remain Available to Reprocess Other Flexible Endoscopes: FDA Safety Comm.