Device Listing 1202004332
Listing Summary#
- Listing key
- 1202004332
- Premarket submission
- K151565
- Device
- Xpert® TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Collection Kit
- Applicant
- Cepheid
- Product code
- OUY
- Decision date
- 2015-10-16