De Novo DEN130042
- Device
- MISEQDX UNIVERSAL KIT 1.0
- Contact
- leanne m kiviharju
- De Novo number
- DEN130042
- Product code
- PFT
- Regulation
- 862.3800
- Classification name
- reagents for molecular diagnostic test systems
- Decision
- granted (DENG)
- Decision date
- 2013-11-19
- Date received
- 2013-10-04
- Classification advisory
- Clinical Chemistry
- Review advisory
- Clinical Chemistry
- Type
- Direct
Current FDA Classification#
- Product code
- PFT
- Device name
- Reagents For Molecular Diagnostic Test Systems
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation
- 862.3800
- Implant
- N
- Life sustain/support
- N