The following data is part of a premarket notification filed by Cepheid with the FDA for Xpert Xpress Flu/rsv, Xpert Nasopharyngeal Sample Collection Kit, Genexpert Dx Systems (gx-i, Gx-ii, Gx-iv, Gx-xvi), Genexpert Infinity-48 System And Genexpert Infinity-48s System, Genexpert Infinity-80 System.
| Device ID | K162331 |
| 510k Number | K162331 |
| Device Name: | Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System And GeneXpert Infinity-48s System, GeneXpert Infinity-80 System |
| Classification | Respiratory Virus Panel Nucleic Acid Assay System |
| Applicant | CEPHEID 904 CARIBBEAN DRIVE Sunnyvale, CA 94089 |
| Contact | Scott A. Campbell |
| Correspondent | Jim Kelly 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-19 |
| Decision Date | 2017-02-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332940005696 | K162331 | 000 |