Device product
DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01
Z-3306-2024
Product summary
- Event
- Event 95288
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 150,000 kits
- Official record key
device-enforcement:Z-3306-2024
Official wording
Reason: The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.
Code information: All lots in the United States
Distribution pattern: International distribution to the countries of China and Hong Kong.
Derived failure modes
-
Unknown
The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.