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Device Classifications For COVID, Acute Febrile Illness IVDs And Force Separation Catheters

 
• By Hannah Daniel

The FDA designated class II special controls classifications for two diagnostics and force separation catheters. 

WHITE OAK, MD - JULY 20: A sign for the Food And Drug Administration is seen outside of the headquarters on July 20, 2020 in White Oak, Maryland. (Photo by Sarah Silbiger/Getty Images)
• Source: Sarah Silbiger/Getty Images (Sarah Silbiger/Getty Images)

Three new general devices were classified as class II with special controls by the US Food and Drug Administration, all effective 16 August.

Two general classifications came about from de novo devices made by BioFire Diagnostics Inc.. On 20 November 2020, Biofire...

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Whoops! FDA Says Company Marketed Unauthorized Device. The Company Says The FDA Is Wrong

 
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