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In this section: Substantially Equivalent 510(k) Device Information

BR190330 - Sentosa SQ HIV-1 Genotyping Assay

De Novo Number: BR190330
Applicant: Vela Diagnostics USA Inc.
Device Name: Sentosa® SQ HIV-1 Genotyping Assay
Decision Date: 11/5/2019

Supporting Documents:

BR190330 De Novo Classification Order
BR190330 De Novo Decision Summary
BR190330 Package Insert

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