De Novo DEN230092
- Device
- Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390)
- Contact
- michele chwedoruk
- De Novo number
- DEN230092
- Product code
- SBT
- Regulation
- 866.3967
- Classification name
- device to detect microbial colonization directly from clinical specimens.
- Decision
- granted (DENG)
- Decision date
- 2024-07-15
- Date received
- 2023-12-28
- Classification advisory
- Microbiology
- Review advisory
- Microbiology
- Type
- Direct
Current FDA Classification#
- Product code
- SBT
- Device name
- Device To Detect Microbial Colonization Directly From Clinical Specimens.
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation
- 866.3967
- Implant
- N
- Life sustain/support
- N