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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 nucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections
De Novo Number DEN180047
Device Name Aptima Mycoplasma genitalium Assay
Hologic, Inc.
10210 genetic center drive
san diego,  CA  92121
Contact jeffrey hergesheimer
Regulation Number866.3393
Classification Product Code
Date Received08/31/2018
Decision Date 01/23/2019
Decision granted (DENG)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct