The following data is part of a De Novo classification by Hologic, Inc. with the FDA for Aptima Mycoplasma Genitalium Assay.
| DeNovo ID | DEN180047 |
| Device Name: | Aptima Mycoplasma Genitalium Assay |
| Classification | Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections |
| Applicant | Hologic, Inc. 10210 Genetic Center Drive San Diego, CA 92121 |
| Contact | Jeffrey Hergesheimer |
| Product Code | QEP |
| CFR Regulation Number | 866.3393 [🔎] |
| Decision | Granted (DENG) |
| Review Advisory Board | Microbiology |
| Classification Advisory | Molecular Genetics |
| Type | Direct |
| Date Received | 2018-08-31 |
| Decision Date | 2019-01-23 |