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Medical Devices / Submissions and Approvals

Mesa Biotech Gains 510(k) Clearance for RSV Test

Nov. 29, 2018
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The FDA granted Mesa Biotech 510(k) clearance for its Accula respiratory syncytial virus (RSV) molecular point-of-care test. The test received the CE Mark in Europe earlier this month.

The test diagnoses RSV, which is highly contagious and frequently affects young children and elderly adults, who experience more serious complications from the virus.

The test is designed for use with the company’s polymerase chain reaction testing platform, which was specifically made for point-of-care infectious disease diagnosis.

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