Device product
Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02
Z-0001-2023
Product summary
- Event
- Event 90773
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 620,000 tests
- Official record key
device-enforcement:Z-0001-2023
Official wording
Reason: Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, or a Pre-Market Approval or Clearance.
Code information: Catalog Number: CO-02 UDI-DI Code: No UDI Codes provided Lot Numbers: 202107192, 202108231, 202109231, 202111082, 202110111, 202201102,
Distribution pattern: U.S.: CA (pending firm supplying additional distribution locations/consignee list). O.U.S.: N/A
Derived failure modes
-
Unknown
Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, or a Pre-Market Approval or Clearance.