Device product
Diagnostic Kit SARS-cCo V Antigen Rapid Test
Z-1050-2022
Product summary
- Firm
- USA Medical, LLC
- Event
- Event 90098
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2055 kits
- Official record key
device-enforcement:Z-1050-2022
Official wording
Reason: COVID-19/SARS-CoV-2 Antigen Tests did not receive FDA Emergency Use Authorization, nor were the tests cleared or approved to be commercially distributed.
Code information: Catalog/Model/Part Number: None UDI Code: None Lot Numbers: Unknown/None
Distribution pattern: U.S. Nationwide distribution in the states of CA, FL, IN, MD, MO, NJ, OK, and TN.
Derived failure modes
-
Unknown
COVID-19/SARS-CoV-2 Antigen Tests did not receive FDA Emergency Use Authorization, nor were the tests cleared or approved to be commercially distributed.