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Medical Devices / Submissions and Approvals

Omega Diagnostics HIV Test Scores CE Mark

Dec. 1, 2017

UK-based Omega Diagnostics Group scored a CE Mark for its VISITECT CD4 HIV test.

The disposable test is designed to determine immune status of patients diagnosed with the HIV infection with whole blood samples.

The company said the CE Mark approval “forms the basis of the additional regulatory approval it will seek through the World Health Organization prequalification program.”

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