Ortho Clinical Diagnostics' Vitros Immunodiagnostic Product 25-OH Vitamin D Total assay has received CE mark approval.
The Vitros 25-OH Vitamin D Total assay is a new diagnostic blood test designed to measure levels of vitamin D2 and vitamin D3 in human serum and plasma and for use on the company's specific automated VITROS platforms.
Automated VITROS platform includes Vitros ECi/ECiQ Immunodiagnostic Systems, the Vitros 3600 Immunodiagnostic System, and the Vitros5600 Integrated System.
The results obtained through 25-OH Vitamin D Total assay are used in the evaluation of vitamin D sufficiency and also may be used in conjunction with other clinical or laboratory data to assist the clinician in patient management.
Ortho Clinical Diagnostics scientific affairs manager Lily Li said, "With CE Marking of the fully-automated VITROS Immunodiagnostic Product 25-OH Vitamin D Total Assay, OCD can now offer European customers a vitamin D test that provides equal detection of vitamin D2 and D3 for a more accurate evaluation of the patient's overall vitamin D status."
The company recently filed a 510(k) application of Vitros 25-OH Vitamin D Total assay to the US Food and Drug Administration, which is still in pending approval.
