Skip to contentDe Novo DEN170041
- Device
- GeneSTAT.MDx Coccidioides Assay
- Contact
- ernie sumsion
- De Novo number
- DEN170041
- Product code
- QAA
- Regulation
- 866.3376
- Classification name
- coccidioides spp. nucleic acid detection system for respiratory specimens
- Decision
- granted (DENG)
- Decision date
- 2017-11-29
- Date received
- 2017-08-01
- Classification advisory
- Microbiology
- Review advisory
- Microbiology
- Type
- Direct
Current FDA Classification#
- Product code
- QAA
- Device name
- Coccidioides Spp. Nucleic Acid Detection System For Respiratory Specimens
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation
- 866.3376
- Implant
- N
- Life sustain/support
- N