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Diagnostics Regulatory News & FDA Approvals

The latest regulatory news and FDA approvals.

The product, which received the CE mark earlier this year, uses digital imaging and AI to automate peripheral blood smear analysis.

The assay does not require nucleic acid extraction or purification, unlike a LumiraDx SARS-CoV-2 test that received Emergency Use Authorization in August.

DNA Genotek's devices are used with SARS-CoV-2 tests from Clinical Reference Laboratory and P23 Labs, while Clinical Enterprises' kit is offered by Eurofins.

The company said its rapid antigen test provides results in 15 minutes and is easy to administer for healthcare professionals using a nasopharyngeal swab.

The new guidance allows developers to use other transport media and sample types without first obtaining 510(k) clearance.