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BD Gets CE-IVD Mark for Point-of-Care Coronavirus Antigen Test

NEW YORK — Becton Dickinson said on Wednesday that it has received CE-IVD marking for its point-of-care BD Veritor Plus SARS-CoV-2 antigen test.

The test will be available in Europe by the end of October, BD said.

The assay operates on the Franklin Lakes, New Jersey-based company's portable BD Veritor Plus System and provides results in 15 minutes. BD aims to produce 8 million of the SARS-CoV-2 tests a month by October and 12 million tests a month by March 2021.

In early July, the test received Emergency Use Authorization from the US Food and Drug Administration. That same month, the US Department of Health and Human Services agreed to purchase 2,000 of the BD Veritor Plus instruments and 750,000 of the SARS-CoV-2 tests, then partnered with the US Department of Defense to provide BD with $24 million to scale up production of the assay.