The following data is part of a De Novo classification by Asuragen, Inc. with the FDA for Quantidex Qpcr Bcr-abl Is Kit.
| DeNovo ID | DEN160003 |
| Device Name: | Quantidex QPCR BCR-ABL IS Kit |
| Classification | Bcr/abl1 Monitoring Test |
| Applicant | ASURAGEN, INC. 2150 Woodward, Suite 100 Austin, TX 78744 |
| Contact | Fayyaz Memon |
| Product Code | OYX |
| CFR Regulation Number | 866.6060 [🔎] |
| 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 | Molecular Genetics |
| Classification Advisory | Molecular Genetics |
| Type | Direct |
| Date Received | 2016-01-19 |
| Decision Date | 2016-07-22 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863840000223 | DEN160003 | 000 |