Skip to contentDe Novo DEN240045
- Device
- Teal Wand
- Contact
- trena depel
- De Novo number
- DEN240045
- Product code
- SEP
- Regulation
- 866.2920
- Classification name
- device for home collection and transport of vaginal specimens by lay users for use in an approved hpv molecular assay
- Decision
- granted (DENG)
- Decision date
- 2025-05-09
- Date received
- 2024-08-27
- Classification advisory
- Microbiology
- Review advisory
- Microbiology
- Type
- Direct
Current FDA Classification#
- Product code
- SEP
- Device name
- Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation
- 866.2920
- Implant
- N
- Life sustain/support
- N