Danaher subsidiary Leica Biosystems said Monday that it secured US Food and Drug Administration 510(k) clearance for its Bond MMR Antibody Panel to help identify potential Lynch syndrome in colorectal cancer patients.
The US Food and Drug Administration this week released its guidance document for developers of medical devices for COVID-19, including diagnostic tests, on how to transition from Emergency Use Authorization to full marketing and regulatory authorization.
Supplies of laboratory reagents, testing components and transport media are expected to normalize in the first half of 2023, ending shortages that date back to early in the pandemic, according to the Food and Drug Administration.
Genomadix announced on Wednesday that the US Food and Drug Administration has granted 510(k) clearance to its automated sample-to-result Genomadix Cube PCR system and CYP2C19 test.
DiaSorin said late Friday that it has nabbed US Food and Drug Administration 510(k) clearance for a molecular assay that differentiates between infections with the SARS-CoV-2 and influenza A and B viruses.
Cue Health announced on Monday that it has received Emergency Use Authorization from the US Food and Drug Administration for its molecular monkeypox test.
Becton Dickinson announced that it received 510(k) clearance from the US Food and Drug Administration for a high-throughput assay to detect vaginitis.
Visby Medical said that it has received 510(k) clearance and a CLIA waiver from the US Food and Drug Administration for its second-generation point-of-care sexual health test.
QuidelOrtho Corporation, a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, announced today that it has been granted a De Novo request from the U.S. Food and Drug Administration (FDA).
Abbott announced on Tuesday that its laboratory-based test for traumatic brain injuries has received clearance from the US Food and Drug Administration.
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