Device Listing 1970984317
Listing Summary#
- Listing key
- 1970984317
- Premarket submission
- K181289
- Device
- Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System and GeneXpert Infinity-80 System
- Applicant
- Cepheid
- Product code
- OCC
- Decision date
- 2018-08-15