Ortho Sera extended blood typing clears FDA

2019 05 18 00 32 7363 Blood Cells 200

Ortho Clinical Diagnostics has announced the U.S. Food and Drug Administration (FDA) clearance of its Ortho Sera ID-Micro Typing System (MTS) extended antigen phenotyping in blood transfusion products, for use on the company's Ortho Vision analyzer.

Phenotyping is done prior to blood transfusions to determine if patients have antibodies to various blood group antigens; extended phenotyping is performed when patients may have developed atypical antibodies. According to the company, Ortho Sera covers more than 99% of the most commonly tested antigens. Extended phenotyping is completed in an automated fashion on one platform, with results available in 20 minutes, the company noted in a statement.

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