Skip to contentDe Novo DEN220042
- Device
- Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)
- Contact
- catalano maximiliano
- De Novo number
- DEN220042
- Product code
- QVB
- Regulation
- 880.2806
- Classification name
- biological sterilization indicator with indirect growth detection
- Decision
- granted (DENG)
- Decision date
- 2024-07-12
- Date received
- 2022-07-01
- Classification advisory
- General Hospital
- Review advisory
- General Hospital
- Type
- Direct
Current FDA Classification#
- Product code
- QVB
- Device name
- Biological Sterilization Indicator With Indirect Growth Detection
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation
- 880.2806
- Implant
- N
- Life sustain/support
- N