The following data is part of a premarket notification filed by Cepheid with the FDA for Xpert Flu.
| Device ID | K123191 |
| 510k Number | K123191 |
| Device Name: | XPERT FLU |
| Classification | Respiratory Virus Panel Nucleic Acid Assay System |
| Applicant | CEPHEID 904 CARIBBEAN DRIVE Sunnyvale, CA 94089 -1189 |
| Contact | Russel K Enns |
| Correspondent | Russel K Enns CEPHEID 904 CARIBBEAN DRIVE Sunnyvale, CA 94089 -1189 |
| Product Code | OCC |
| Subsequent Product Code | OOI |
| Subsequent Product Code | OQW |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-11 |
| Decision Date | 2012-12-21 |
| Summary: | summary |