Skip to content
De Novo DEN160025
- Device
- ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit
- Contact
- jyotsna shah
- De Novo number
- DEN160025
- Product code
- PYN
- Regulation
- 866.3367
- Classification name
- fish (fluorescence in situ hybridization) kit, nucleic acid, plasmodium sp.
- Decision
- granted (DENG)
- Decision date
- 2017-08-18
- Date received
- 2016-06-27
- Classification advisory
- Microbiology
- Review advisory
- Microbiology
- Type
- Direct
Current FDA Classification#
- Product code
- PYN
- Device name
- Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation
- 866.3367
- Implant
- N
- Life sustain/support
- N