The following data is part of a premarket notification filed by Cepheid with the FDA for Xpert Tv, Xpert Urine Specimen Collection Kit, Genexpert Dx Systems (gx-i, Gx-ii, Gx-iv, Gx-xvi), Genexpert Infinity-48, Genxpert Infinity-48s And Genexpert Infinity-80 Systems.
| Device ID | K161619 |
| 510k Number | K161619 |
| Device Name: | Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s And GeneXpert Infinity-80 Systems |
| Classification | Trichomonas Vaginalis Nucleic Acid Amplification Test System |
| Applicant | Cepheid 904 Carribean Drive Sunnyvale, CA 94089 -1189 |
| Contact | Scott A. Campbell |
| Correspondent | Scott A. Campbell Cepheid 904 Carribean Drive Sunnyvale, CA 94089 -1189 |
| Product Code | OUY |
| Subsequent Product Code | JSM |
| Subsequent Product Code | OOI |
| CFR Regulation Number | 866.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-13 |
| Decision Date | 2016-08-29 |
| Summary: | summary |