The following data is part of a premarket notification filed by Cepheid with the FDA for Xpert, Genexpert Dx System.
| Device ID | K060540 |
| 510k Number | K060540 |
| Device Name: | XPERT, GENEXPERT DX SYSTEM |
| Classification | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test |
| Applicant | CEPHEID 904 CARIBBEAN DRIVE Sunnyvale, CA 94089 -1189 |
| Contact | Russel K Enns |
| Correspondent | Russel K Enns CEPHEID 904 CARIBBEAN DRIVE Sunnyvale, CA 94089 -1189 |
| Product Code | NJR |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-01 |
| Decision Date | 2006-07-25 |
| Summary: | summary |