Skip to contentDe Novo DEN060008
- Device
- INFLUENZA A/H5 (ASIAN LINEAGE) VIRUS REAL-TIME RT-PCR PRIMER AND PROBE SET
- Contact
- hye-joo kim
- De Novo number
- DEN060008
- Product code
- NXD
- Regulation
- 866.3332
- Classification name
- nucleic acid amplification, novel influenza a virus, a/h5 (asian lineage) rna
- Decision
- granted (DENG)
- Decision date
- 2006-02-03
- Date received
- 2006-01-27
- Classification advisory
- Microbiology
- Review advisory
- Microbiology
- Type
- Post-NSE
Current FDA Classification#
- Product code
- NXD
- Device name
- Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation
- 866.3332
- Implant
- N
- Life sustain/support
- N