The following data is part of a De Novo classification by Orasure Technologies, Inc. with the FDA for Oraquick Ebola Rapid Antigen Test.
| DeNovo ID | DEN190025 |
| Device Name: | OraQuick Ebola Rapid Antigen Test |
| Classification | Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens |
| Applicant | OraSure Technologies, Inc. 220 East First Street Bethlehem, PA 18015 |
| Contact | Tiffany Miller |
| Product Code | QID |
| CFR Regulation Number | 866.4002 [🔎] |
| 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 | 2019-05-13 |
| Decision Date | 2019-10-10 |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00608337001433 | DEN190025 | 000 |