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, Xpert Nasal Sample Collection Kit, Genexpert Xpress Ii, Genexpert Xpress Iv.
| Device ID | K180218 |
| 510k Number | K180218 |
| Device Name: | Xpert Xpress Flu/RSV, 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 |
| 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 | Dual Track |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-25 |
| Decision Date | 2018-07-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332940007195 | K180218 | 000 |