The following data is part of a premarket notification filed by Cepheid with the FDA for Xpert Xpress Strep A.
| Device ID | K173398 |
| 510k Number | K173398 |
| Device Name: | Xpert Xpress Strep A |
| Classification | Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification 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 | PGX |
| CFR Regulation Number | 866.2680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Dual Track |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-31 |
| Decision Date | 2018-04-26 |