Aptima Mycoplasma Genitalium Assay

Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections

Hologic, Inc.

The following data is part of a De Novo classification by Hologic, Inc. with the FDA for Aptima Mycoplasma Genitalium Assay.

Pre-market Notification Details

DeNovo IDDEN180047
Device Name:Aptima Mycoplasma Genitalium Assay
ClassificationNucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections
Applicant Hologic, Inc. 10210 Genetic Center Drive San Diego,  CA  92121
ContactJeffrey Hergesheimer
Product CodeQEP  
CFR Regulation Number866.3393 [🔎]
DecisionGranted (DENG)
Review Advisory BoardMicrobiology
Classification AdvisoryMolecular Genetics
TypeDirect
Date Received2018-08-31
Decision Date2019-01-23

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