7 July 2020 - - The US Food and Drug Administration issued an Emergency Use Authorization for a COVID-19 antigen diagnostic test, the BD (Becton Dickinson) (NYSE: BDX) Veritor System for Rapid Detection of SARS-CoV-2, the agency said.

This is the second antigen test the FDA has authorized for the detection of SARS-CoV-2 antigens.

This test is authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 for high, moderate, or waived complexity testing, meaning it can be used in patient care settings operating under a CLIA certificate of Waiver, certificate of Compliance, or certificate of Accreditation.

Emergency use of this test is limited to authorized laboratories using the BD Veritor Plus Analyzer Instrument.

The FDA, an agency within the US Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.