The following data is part of a De Novo classification by Luminex Molecular Diagnostics, Inc. with the FDA for Xtag Gastrointestinal Pathogen Panel (gpp) Xtag Data Analysis Software For Gpp (tdas).
| DeNovo ID | DEN130003 |
| Device Name: | XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP) XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS) |
| Classification | Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System |
| Applicant | LUMINEX MOLECULAR DIAGNOSTICS, INC. 439 University Ave. suite 900 Toronto, CA M5g 1y8 |
| Contact | Lubna Syed |
| Product Code | PCH |
| CFR Regulation Number | 866.3990 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K121454 |
| Review Advisory Board | Microbiology |
| Classification Advisory | Microbiology |
| Type | Post-NSE |
| Date Received | 2013-01-11 |
| Decision Date | 2013-01-14 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |