Device Listing 1644229901
Listing Summary#
- Listing key
- 1644229901
- Premarket submission
- DEN230092
- Device
- Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)
- Applicant
- Diasorin Molecular, LLC
- Product code
- SBT
- Decision date
- 2024-07-15