FDA-Device2022-04-27Class II
Virus Counter Platform with Model Name VC3100
Sartorius Corporation
Hazard
The Virus Counter is an automated laboratory instrument that enables rapid quantification of intact viruses in solution. This instrument is not a medical device. The virus quantification is used in process development and manufacturing of various biotechnology products such as vaccines, gene therapy and personalized immunotherapy. Device is a Class 1 laser flow cytometer.
Sold states
US Nationwide distribution.
Affected count
82
Manufactured in
6542 Fig St, Arvada, CO, United States
Products
Virus Counter Platform with Model Name VC3100
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0946-2022Don't want to check this manually?
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