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Osang Healthcare, Xiamen Boson Biotech Get FDA Emergency Use Authorization for COVID-19 Antigen Test

NEW YORK — The US Food and Drug Administration this week granted separate Emergency Use Authorizations for over-the-counter SARS-CoV-2 antigen self-tests developed by Osang Healthcare and Xiamen Boson Biotech.

Osang's OHC COVID-19 Antigen Self Test is a lateral flow immunoassay designed for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in self-collected or adult-collected anterior nasal swabs.

About a year ago, South Korea-based Osang inked a US distribution deal for its GeneFinder COVID-19 Plus RealAmp Kit with Todos Medical.

Xiamen Boson's Rapid SARS-CoV-2 Antigen Test Card is also a lateral flow immunoassay designed to detect SARS-CoV-2 nucleocapsid protein antigen in self- or adult-collected anterior nasal swab specimens.

In early 2021, the Xiamen, China-based company received approval from German regulators for the test.

The FDA said in a statement that both tests can provide results in 15 minutes. They can also be used for serial testing for individuals with or without symptoms.