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Medical Devices / Submissions and Approvals

Cepheid Achieves FDA Clearance and CLIA Waiver for Flu Assay

Jan. 12, 2018

California-based molecular diagnostic company Cepheid achieved FDA clearance and a Clinical Laboratory Improvement Amendments waiver for its Xpert Xpress Flu test.

The test is indicated for use in near-patient settings for the detection of Flu A and B RNA.

It can be performed using patients’ nasal swabs in under 20 minutes.

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