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NEW YORK – Ortho Clinical Diagnostics said on Friday that it has received the CE mark for its Vitros Immunodiagnostic Products TSH3 reagent pack and calibrator.

The test for diagnosing thyroid and/or pituitary gland function will be commercially available starting in December, the Raritan, New Jersey-based company said, adding it should be particularly useful in Europe where studies have shown that almost half of people there who have thyroid dysfunction don't know about their condition. About 11 percent of Europeans have thyroid dysfunction, Ortho Clinical Dx said.

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