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Medical Devices / Submissions and Approvals

FDA Grants Clearance for Alere Reader Platform and Alere BinaxNOW Influenza A & B Card 2

April 12, 2017
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Massachusetts–based Alere has won FDA marketing clearance for its Alere Reader, a diagnostic analyzer that can be used in point-of-care and laboratory settings.

The device will be initially available for use with the BinaxNOW Influenza A & B Card 2, with other lateral flow applications and assays to follow. The reformulated test card has achieved Class II designation under the new FDA reclassification requirements.

The Alere Reader is a further extension of the company’s flu portfolio.

The device also received in-vitro diagnostic CE marking in August 2016. — Cynthia Jessup

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