The following data is part of a De Novo classification by Advance Sentry Corporation with the FDA for Np Screen.
| DeNovo ID | DEN190031 |
| Device Name: | NP Screen |
| Classification | Device To Detect Or Measure Nucleic Acid From Viruses Associated With Head And Neck Cancers |
| Applicant | Advance Sentry Corporation 7155 Woodbine Avenue, Suite 202 Markham, CA L3r 1a3 |
| Contact | Leo Chui |
| Product Code | OJY |
| CFR Regulation Number | 866.3236 [🔎] |
| 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 | 2019-06-24 |
| Decision Date | 2020-05-11 |
| Reclassification Order: | Reclassification Order |