Skip to contentDe Novo DEN240016
- Device
- Xpert HCV; GeneXpert Xpress System
- Contact
- suzette chance
- De Novo number
- DEN240016
- Product code
- SBP
- Regulation
- 866.3171
- Classification name
- simple point-of-care nucleic acid-based hepatitis c virus ribonucleic acid test
- Decision
- granted (DENG)
- Decision date
- 2024-06-27
- Date received
- 2024-04-16
- Classification advisory
- Microbiology
- Review advisory
- Microbiology
- Type
- Direct
Current FDA Classification#
- Product code
- SBP
- Device name
- Simple Point-Of-Care Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Test
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation
- 866.3171
- Implant
- N
- Life sustain/support
- N