De Novo DEN140002
- Device
- EUROIMMUN ANTI-PLA2R IFA
- Contact
- michael locke
- De Novo number
- DEN140002
- Product code
- PGV
- Regulation
- 866.5780
- Classification name
- anti-phospholipase a2 receptor
- Decision
- granted (DENG)
- Decision date
- 2014-05-29
- Date received
- 2014-03-28
- Classification advisory
- Microbiology
- Review advisory
- Immunology
- Type
- Post-NSE
Current FDA Classification#
- Product code
- PGV
- Device name
- Anti-Phospholipase A2 Receptor
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation
- 866.5780
- Implant
- N
- Life sustain/support
- Y