FDA-Device2024-10-09Class II
DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01
FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD
Hazard
The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.
Sold states
International distribution to the countries of China and Hong Kong.
Affected count
120,000 kits
Manufactured in
No. 1304 Science And Technology Innovation Park, Shajing Dahong, N/A, Shenzhen, N/A, China
Products
DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3307-2024Don't want to check this manually?
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