Device Listing 1134766136
Listing Summary#
- Listing key
- 1134766136
- Premarket submission
- K162331
- Device
- Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48 System and GeneXpert Infinity-48s System, GeneXpert Infinity-80 System
- Applicant
- Cepheid
- Product code
- OCC
- Decision date
- 2017-02-09