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Cue Health Makes De Novo Submission to FDA for Full Clearance of its Cue RSV Molecular Test - Vimarsana News

Cue Health Makes De Novo Submission to FDA for Full Clearance of its Cue RSV Molecular Test

09.05.2023 - Cue Health (“Cue”) (Nasdaq: HLTH), a healthcare technology company, today announced that it has made a De Novo submission to the U.S. Food and Drug Administration (FDA) for full clearance of the Cue RSV Molecular Test for at-home and point-of-care ... Seite 1

Cue Health Submits At-Home Molecular RSV Assay to FDA - Vimarsana News

Cue Health Submits At-Home Molecular RSV Assay to FDA

The de novo submission is for a molecular diagnostic test for respiratory syncytial virus meant for home and point-of-care use.

Cue Health Applies with FDA for Emergency Use Authorization of its Cue Flu + COVID-19 Molecular Test - Vimarsana News

Cue Health Applies with FDA for Emergency Use Authorization of its Cue Flu + COVID-19 Molecular Test

/PRNewswire/ -- Cue Health ("Cue") (Nasdaq: HLTH), a healthcare technology company that puts diagnostic information at the center of care, today announced that...