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Medical Devices / Submissions and Approvals

Mesa Biotech Obtains CE Mark for Respiratory Syncytial Virus Test

Nov. 14, 2018

The EU granted Mesa Biotech’s respiratory syncytial virus (RSV) point-of-care test the CE Mark.

The test, which diagnoses the highly contagious RNA virus, is designed for use with the devicemaker’s polymerase chain reaction testing platform.

The RNA virus affects nearly all children by the time they are two years old and is severe in children with underlying diseases.

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