De Novo DEN200015
- Device
- cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit
- Contact
- rita hoady
- De Novo number
- DEN200015
- Product code
- QLX
- Regulation
- 866.3183
- Classification name
- nucleic acid amplification test for the quantitation of epstein-barr virus (ebv) dna
- Decision
- granted (DENG)
- Decision date
- 2020-07-30
- Date received
- 2020-03-02
- Classification advisory
- Microbiology
- Review advisory
- Microbiology
- Type
- Direct
Current FDA Classification#
- Product code
- QLX
- Device name
- Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation
- 866.3183
- Implant
- N
- Life sustain/support
- N