Bio-Rad receives FDA clearance for IH-1000 blood typing instrument for the U.S. market

Bio-Rad Laboratories, Inc., a global provider of life science research and clinical diagnostic products, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its IH-1000 blood typing instrument along with approvals for a wide range of associated gel cards and reagents for the U.S. blood typing market. The system offers full automation and walk-away reliability, allowing laboratories to more efficiently manage their blood testing workload.

With the release of the IH-1000 system and associated gel cards and reagents, Bio-Rad offers a wide variety of platforms, reagents, data management, and connectivity solutions to support different volume blood testing needs of the U.S. market. These products include Bio-Rad's TANGO infinity™ system as well as a comprehensive range of reagents for conventional tube testing.

"We are pleased the FDA has cleared the way for us to bring the IH-1000 and associated products to the U.S.," said John Hertia, Bio-Rad Executive Vice President and President, Clinical Diagnostics Group. "With the availability of the IH-1000 system and gel cards, our TANGO infinity™ system, along with our comprehensive line of reagents, data management, and networking capability, customers now have the convenience and flexibility to select product solutions to optimize their laboratory workflow," he added.

The IH-1000 system includes the IH-1000 automated instrument, a wide range of gel cards, associated reagents, and IH-Com software for managing data and patient results and connections to the laboratory information system (LIS). The IH-1000 instrument is designed for rapid sample processing with continuous access, and it incorporates a number of important safety features. Together, these solutions offer our customers efficient and reliable results for blood grouping, reverse grouping, phenotyping, cross matching, antibody screening, antibody identification, direct AHG tests, and single antigen screens.

Source: https://www.aacc.org/meetings-and-events/2017-annual-meeting