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 Xpress Ii, Genexpert Xpress Iv.
| Device ID | K171552 |
| 510k Number | K171552 |
| Device Name: | Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV |
| Classification | Respiratory Virus Panel Nucleic Acid Assay System |
| Applicant | Cepheid 904 Caribbean Drive Sunnyvale, CA 94089 -1189 |
| Contact | Yi-ping Lin |
| Correspondent | Jim Kelly Cepheid 904 Caribbean Drive Sunnyvale, CA 94089 -1189 |
| 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 | 2017-05-26 |
| Decision Date | 2017-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332940002565 | K171552 | 000 |
| 07332940006457 | K171552 | 000 |
| 07332940009243 | K171552 | 000 |