CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
October 2019—Bio-Rad Laboratories received FDA 510(k) clearance for its IH-500, an automated random access system for blood typing and screening, designed for small to medium-size laboratories. The system can process Bio-Rad’s range of IH gel cards for ABO blood grouping, reverse testing, phenotyping, Rh subgroups, antibody screening, antibody identification, single antigen testing, direct AHG testing, and crossmatching.
In a separate release, the company announced FDA clearance for its BioPlex 2200 Lyme Total Assay, a multiplex test method to aid in the diagnosis of Lyme disease. It runs on the BioPlex 2200 System.
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