The following data is part of a premarket notification filed by Cepheid with the FDA for Xpert Flu+rsv Xpress, Xpert Nasopharyngeal Sample Collection Kit, Genexpert Xpress System (gx-i).
| Device ID | K151226 |
| 510k Number | K151226 |
| Device Name: | Xpert Flu+RSV Xpress, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Xpress System (GX-I) |
| Classification | Respiratory Virus Panel Nucleic Acid Assay System |
| Applicant | CEPHEID 904 CARIBBEAN DRIVE Sunnyvale, CA 94089 |
| Contact | Kerry J Flom |
| Correspondent | Scott A Campbell CEPHEID 904 CARIBBEAN DRIVE Sunnyvale, CA 94089 |
| Product Code | OCC |
| Subsequent Product Code | JSM |
| Subsequent Product Code | OOI |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Dual Track |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-07 |
| Decision Date | 2015-12-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332940005177 | K151226 | 000 |