De Novo DEN130049
- Device
- SIMPLEXA HSV 1&2 DIRECT
- Contact
- sharon young
- De Novo number
- DEN130049
- Product code
- PGH
- Regulation
- 866.3307
- Classification name
- hsv-1 and hsv-2 cns nucleic-acid based panel
- Decision
- granted (DENG)
- Decision date
- 2014-03-21
- Date received
- 2013-11-25
- Classification advisory
- Microbiology
- Review advisory
- Microbiology
- Type
- Direct
Current FDA Classification#
- Product code
- PGH
- Device name
- Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation
- 866.3307
- Implant
- N
- Life sustain/support
- Y