The following data is part of a premarket notification filed by Cepheid with the FDA for Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, Genexpert Dx Systems (gx-i, Gx-ii, Gx-iv, Gx-xvi), Genexpert Infinity-48s System And Genexpert Infinity-80 System.
| Device ID | K181289 |
| 510k Number | K181289 |
| Device Name: | Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System And GeneXpert Infinity-80 System |
| Classification | Respiratory Virus Panel Nucleic Acid Assay System |
| Applicant | Cepheid 904 Caribbean Drive Sunnyvale, CA 94089 |
| Contact | Yi-ping Lin |
| 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 | 2018-05-16 |
| Decision Date | 2018-08-15 |
| Summary: | summary |