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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name hiv-1 genotyping assay using ngs technology
De Novo Number BR190330
Device Name Sentosa SQ HIV Genotyping Assay
Product CodeQIC
Device ClassII
Regulation Number866.3955
Submission Type Direct De Novo
Requestor
Vela Diagnostics USA Inc
353 c us route 46 west
suite 250
fairfield,  NJ  07004
Date Received03/19/2019
Decision Date 11/05/2019
DecisionGranted - Direct De Novo
Expedited Review No
Third Party Review Not Third Party Elligble
In Vitro Device? Yes
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