The following data is part of a premarket notification filed by Cepheid with the FDA for Xpert Gbs Lb Xc, Genexpert Dx System, Genexpert Infinity System.
| Device ID | K203429 |
| 510k Number | K203429 |
| Device Name: | Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System |
| Classification | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test |
| Applicant | Cepheid 904 Caribbean Drive Sunnyvale, CA 94089 |
| Contact | Yi-Ping Lin |
| Correspondent | Robert Resnick Cepheid 904 Caribbean Drive Sunnyvale, CA 94089 |
| Product Code | NJR |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-20 |
| Decision Date | 2022-05-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332940007669 | K203429 | 000 |
| 07332940007652 | K203429 | 000 |