De Novo DEN240025
- Device
- VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001)
- Contact
- patricia wade
- De Novo number
- DEN240025
- Product code
- SDP
- Regulation
- 864.1861
- Classification name
- kappa and lambda immunoglobulin light chain in situ hybridization mrna probe detection kit
- Decision
- granted (DENG)
- Decision date
- 2024-12-05
- Date received
- 2024-05-29
- Classification advisory
- Hematology
- Review advisory
- Pathology
- Type
- Direct
Current FDA Classification#
- Product code
- SDP
- Device name
- Kappa And Lambda Immunoglobulin Light Chain In Situ Hybridization Mrna Probe Detection Kit
- Medical specialty
- Hematology
- Device class
- 2
- Regulation
- 864.1861
- Implant
- N
- Life sustain/support
- N