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FDA clears Hologic’s Aptima SARS-CoV-2 assay
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Hologic's Aptima SARS-CoV-2 assay, marking an advancement since its initial emergency use authorisation (EUA) was granted ...
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Hologic announces FDA clearance of Aptima SARS-CoV-2 assay
Hologic (HOLX) announced that the FDA has granted 510(k) clearance for the company’s Aptima SARS-CoV-2 assay, which was first granted Emergency Use Authorization status in May 2020. Published ...