The following data is part of a premarket notification filed by Cepheid with the FDA for Xpert Ct/ng, Genexpert Dx System, Genexpert Infinity-48s And Genexpert Infinity-80 Systems, Genexpert Infinity-48 System, Xpert Vaginal/endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit.
| Device ID | K190441 |
| 510k Number | K190441 |
| Device Name: | Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s And GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit |
| Classification | Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections |
| Applicant | Cepheid 904 Caribbean Drive Sunnyvale, CA 94089 |
| Contact | Yi-ping Lin |
| Correspondent | Sudhakar Marla Cepheid 904 Caribbean Drive Sunnyvale, CA 94089 |
| Product Code | QEP |
| Subsequent Product Code | LSL |
| Subsequent Product Code | MKZ |
| Subsequent Product Code | OOI |
| Subsequent Product Code | QBD |
| CFR Regulation Number | 866.3393 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-25 |
| Decision Date | 2019-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07332940007003 | K190441 | 000 |