The following data is part of a De Novo classification by Dxna, Llc with the FDA for Genestat.mdx Coccidioides Assay.
| DeNovo ID | DEN170041 |
| Device Name: | GeneSTAT.MDx Coccidioides Assay |
| Classification | Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens |
| Applicant | DxNA, LLC 180 N 300 E St George, UT 84770 |
| Contact | Ernie Sumsion |
| Product Code | QAA |
| CFR Regulation Number | 866.3376 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Microbiology |
| Classification Advisory | Microbiology |
| Type | Direct |
| Date Received | 2017-08-01 |
| Decision Date | 2017-11-29 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |