Non-Variola Orthopoxvirus Real-Time Pcr Primer and Probe Set
by Centers for Disease Control and Prevention 5 variants
De Novo DEN070001
Active
De Novo
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA De NovoDENG | NumberDEN070001 | Date21 Sep 2018 | StatusActive |
Recalls
No FDA recalls found in the data synced 11 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA De Novo Active
Specification
- De Novo Number
- FDA Product Code
- PBK
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.3315
- Advisory Committee
- Microbiology
- FDA Decision
- DENG De Novo granted
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