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Immucor Obtains FDA Clearance for Single-Antigen Assays to Identify Donors for Transplants

NEW YORK ─ Immucor on Friday announced that it has obtained US Food and Drug Administration clearance for its Luminex single antigen product Lifecodes LSA Class I and Class II Assays in conjunction with its Match It! Antibody Software.

The Norcross, Georgia-based firm said that its Lifecodes LSA Luminex single-antigen assays demonstrate a low false-positive rate, which increases a clinical laboratory's ability to find acceptable donors for transplants.

The regulatory "milestone highlights Immucor's ongoing investment in our transplant antibody portfolio," Christie Otis, the firm's chief marketing officer, said in a statement.

Immucor plans to expand commercialization of its Lifecodes LSA assays to new markets, she added.