The following data is part of a De Novo classification by Luminex Molecular Diagnostics, Inc. with the FDA for Id-tag Respiratory Viral Panel.
| DeNovo ID | DEN070013 |
| Device Name: | ID-TAG RESPIRATORY VIRAL PANEL |
| Classification | Respiratory Virus Panel Nucleic Acid Assay System |
| Applicant | LUMINEX MOLECULAR DIAGNOSTICS, INC. 439 University Ave. Toronto, Ontario, CA M5g 1y8 |
| Contact | Gloria Lee |
| Product Code | OCC |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K063765 |
| Review Advisory Board | Microbiology |
| Classification Advisory | Microbiology |
| Type | Post-NSE |
| Date Received | 2007-12-04 |
| Decision Date | 2008-01-03 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |