Unauthorized COVID-19 Tests Attract FDA Warning Letter

August 12, 2021

Carson, Calif.-based Biopolygen has drawn an FDA warning letter for marketing unauthorized COVID-19 tests.

The agency cited the company for marketing its COVIGEN AG-1 COVID-19 Self Detection Kit, its COVIDEX AB-1 COVID-19 Self Detection Kit and its COVID-19 Antigen and Antibody Combo Set on its website.

The FDA noted that the unauthorized tests are especially risky because “a lay person [may not have] the ability to collect their specimen, run the test and interpret the test result accurately.”

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