De Novo DEN180040
- Device
- Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit
- Contact
- jack rogers
- De Novo number
- DEN180040
- Product code
- QDZ
- Regulation
- 866.3181
- Classification name
- qualitative cytomegalovirus nucleic acid-based detection device for congenital cytomegalovirus infection
- Decision
- granted (DENG)
- Decision date
- 2018-11-30
- Date received
- 2018-07-30
- Classification advisory
- Microbiology
- Review advisory
- Microbiology
- Type
- Direct
Current FDA Classification#
- Product code
- QDZ
- Device name
- Qualitative Cytomegalovirus Nucleic Acid-Based Detection Device For Congenital Cytomegalovirus Infection
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation
- 866.3181
- Implant
- N
- Life sustain/support
- N