The following data is part of a De Novo classification by Preanalytix Gmbh with the FDA for Paxgene Blood Rna System.
| DeNovo ID | DEN050003 |
| Device Name: | PAXGENE BLOOD RNA SYSTEM |
| Classification | System, Blood Collection, Rna Stabilization, Rna Purification, Rt-pcr Molecular Diagnostic Test |
| Applicant | PREANALYTIX GMBH 1 Becton Drive mc 300 Franklin Lakes, NJ 07417 |
| Contact | Jing Zhang |
| Product Code | NTW |
| CFR Regulation Number | 866.4070 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K042613 |
| Review Advisory Board | Pathology |
| Classification Advisory | Immunology |
| Type | Post-NSE |
| Date Received | 2005-02-28 |
| Decision Date | 2005-04-18 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |