The following data is part of a premarket notification filed by Cepheid with the FDA for Xpert Xpress Mvp, Genexpert Dx System, Genexpert Infinity System.
| Device ID | K212213 |
| 510k Number | K212213 |
| Device Name: | Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System |
| Classification | Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System |
| Applicant | Cepheid 904 Caribbean Drive Sunnyvale, CA 94089 |
| Contact | Suzette Chance |
| Correspondent | Wei Zhang Cepheid 904 Caribbean Drive Sunnyvale, CA 94089 |
| Product Code | PQA |
| CFR Regulation Number | 866.3975 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-15 |
| Decision Date | 2022-02-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332940008345 | K212213 | 000 |
| 07332940007072 | K212213 | 000 |