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Medical Devices / Submissions and Approvals

Mesa Biotech Garners FDA Clearance and CLIA Waiver for Flu Test

Feb. 9, 2018

Mesa Biotech obtained FDA 510(k) clearance and a Clinical Laboratory Improvements Amendments waiver for its Accula Flu A/Flu B test.

The disposable point-of-care test cassette is the first one to receive FDA clearance for use on the company’s polymerase chain reaction Accula testing platform, featuring a portable dock. It can provide test results in about 30 minutes using samples from nasal swabs.

The San Diego-based molecular diagnostic company received a CE Mark for the assay-specific product just last month.

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