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Innova Gets CE Mark Under IVDR Certification For COVID-19 Antigen Test

The story previously incorrectly said that the test was CE marked under the new In Vitro Diagnostic Regulation that went into effect in May. The test received the CE mark under the old In Vitro-Diagnostic Medical Devices Directive 98/79/EC regulation.

NEW YORK – Lateral flow diagnostic company Innova announced on Tuesday that its SARS-CoV-2 rapid antigen test has received CE marking for the Innova SARS-CoV-2 Antigen Rapid Qualitative Self-Test.

The CE mark, received from notified body GMED LNE Group, will allow the firm to sell its test across Europe. The test, which detects multiple proteins in the SARS-CoV-2 virus, had previously been approved for distribution in the UK, Israel, Malaysia, Oman, and Qatar, Innova said in a statement. Since the start of the pandemic, the Pasadena, California-based company has delivered more than 1.5 billion lateral flow tests globally.

"This new European certification only underscores our ongoing commitment to provide effective, high-quality diagnostic products at reasonable prices to more people around the world," Robert Kasprzak, CEO of Innova Medical Group, said in a statement.