De Novo DEN200070
- Device
- Simple 2 Test
- Contact
- karen walsh
- De Novo number
- DEN200070
- Product code
- QYA
- Regulation
- 866.3385
- Classification name
- system for detection of nucleic acid from non-viral microorganism(s) causing stis using specimens collected at home
- Decision
- granted (DENG)
- Decision date
- 2023-11-15
- Date received
- 2020-11-16
- Classification advisory
- Microbiology
- Review advisory
- Microbiology
- Type
- Direct
Current FDA Classification#
- Product code
- QYA
- Device name
- System For Detection Of Nucleic Acid From Non-Viral Microorganism(S) Causing Stis Using Specimens Collected At Home
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation
- 866.3385
- Implant
- N
- Life sustain/support
- N