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Zika Virus Test Among 4 New FDA Device Classifications

 
• By Elizabeth Orr

The FDA plans to announce class II status for four new device types, including tests for the Zika virus and genetic condition Fragile X. This follows earlier announcements and highlights a trend toward diagnostic classifications. The classifications are considered deregulatory, meaning they will hel

Test tube holding blood sample marked positive for Zika virus
(Jarun Ontakrai/Shutterstock)

Classification season continues at the US Food and Drug Administration as the agency prepares to announce class II status for four device types. The classifications will be published in the 29 May Federal Register.

The new classifications are in addition to nine that were announced earlier this month. Like that...

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