De Novo DEN000007
- Device
- QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA
- Contact
- brys c myers
- De Novo number
- DEN000007
- Product code
- NBT
- Regulation
- 866.5785
- Classification name
- antibodies, saccharomyces cerevisiae (s.cerevisiae)
- Decision
- granted (DENG)
- Decision date
- 2000-08-16
- Date received
- 2000-07-18
- Classification advisory
- Immunology
- Review advisory
- Immunology
- Type
- Post-NSE
Current FDA Classification#
- Product code
- NBT
- Device name
- Antibodies, Saccharomyces Cerevisiae (S.Cerevisiae)
- Medical specialty
- Immunology
- Device class
- 2
- Regulation
- 866.5785
- Implant
- N
- Life sustain/support
- N