ClII ViroSeq HIV-1 Genotyping System v2.0

Company: Celera Corporation.
Date of Enforcement Report:10/1/2014
Class lII:


ViroSeq HIV-1 Genotyping System v2.0, consisting of ViroSeq HIV-1 Genotyping System v2.0 reagent kit and Genotyping Software v3.0. Also contains ViroSeq HIV-1 Genotyping Software Manual and System v2.0 (3130) Operators Manual
Recall Number B-0993-14

ViroSeq HIV-1 Genotyping System v2.0, not meeting labeling claim, was distributed..

Celera Corporation, Alameda, CA on 6/18/2014 Voluntary: Firm Initiated recall is ongoing

1 unit

US, Taiwan, Singapore, and Hong Kong.


About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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