FDA-Device2023-02-08Class I
Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT Green and white box under the brand DiagnosUS, and, White box without brand name labeled as "SARS -COV-2 ANTIGEN DEVELOPMENT MADE IN USA ORAL SWAB TESTING
Universal Meditech Inc.
Hazard
Distribution of SARS-CoV-2 Antigen Rapid Test Kits without FDA market approval, clearance or Emergency Use Authorization.
Sold states
U.S. Nationwide distribution in the states of CA, and TX.
Affected count
56,300 kits
Manufactured in
1320 E Fortune Avenue, Suite 102, N/A, Fresno, CA, United States
Products
Products are labeled as: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold) 20 TESTS/1 KIT Green and white box under the brand DiagnosUS, and, White box without brand name labeled as "SARS -COV-2 ANTIGEN DEVELOPMENT MADE IN USA ORAL SWAB TESTING
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0929-2023Don't want to check this manually?
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