The following data is part of a premarket notification filed by Luminex Molecular Diagnostics, Inc. with the FDA for Xtag Respiratory Viral Panel, Xtag Data Analysis Software (tdas Rvp-1).
| Device ID | K112199 |
| 510k Number | K112199 |
| Device Name: | XTAG RESPIRATORY VIRAL PANEL, XTAG DATA ANALYSIS SOFTWARE (TDAS RVP-1) |
| Classification | Respiratory Virus Panel Nucleic Acid Assay System |
| Applicant | LUMINEX MOLECULAR DIAGNOSTICS, INC. 439 UNIVERSITY AVE. SUITE 900 Toronto, Ontario, CA M5g 1y8 |
| Contact | Lubna Syed |
| Correspondent | Lubna Syed LUMINEX MOLECULAR DIAGNOSTICS, INC. 439 UNIVERSITY AVE. SUITE 900 Toronto, Ontario, CA M5g 1y8 |
| Product Code | OCC |
| Subsequent Product Code | NSU |
| Subsequent Product Code | OEM |
| Subsequent Product Code | OEP |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-01 |
| Decision Date | 2011-09-01 |