FDA-Device2022-10-19Class I
Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
Jiangsu Well Biotech Co.,Ltd.
Hazard
Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, or a Pre-Market Approval or Clearance.
Sold states
U.S.: CA (pending firm supplying additional distribution locations/consignee list). O.U.S.: N/A
Affected count
620,000 tests
Manufactured in
No 9 Changyang Rd West, N/A, Changzhou, N/A, China
Products
Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0001-2023Don't want to check this manually?
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