De Novo DEN220044
- Device
- Active Anthrax DetectTM Plus Rapid Test
- Contact
- estela raychaudhuri
- De Novo number
- DEN220044
- Product code
- QUU
- Regulation
- 866.3046
- Classification name
- simple in vitro diagnostic device for the detection of secreted proteins from bacillus spp. in human clinical samples
- Decision
- granted (DENG)
- Decision date
- 2023-02-03
- Date received
- 2022-07-08
- Classification advisory
- Microbiology
- Review advisory
- Microbiology
- Type
- Direct
Current FDA Classification#
- Product code
- QUU
- Device name
- Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation
- 866.3046
- Implant
- N
- Life sustain/support
- N