Bio-Rad Laboratories (NYSE:BIO) said today it has received 510(k) clearance from the FDA for its IH-500 device, an automated random access system for blood typing and screening.
The IH-500 system was designed for small- to medium-sized laboratories, offering automated blood typing and screening based on gel card technology with minimal user intervention. The system can process Bio-Rad’s entire range of IH gel cards for ABO blood grouping, reverse testing, phenotype, Rh-subgroups, antibody screening, antibody identification, single antigen testing, direct AHG testing (DAT), and crossmatch for safety and accuracy, according to the Hercules, Calif.-based company.
“We are pleased to receive FDA clearance for our IH-500 and look forward to extending our reach in the U.S. transfusion medicine market,” said Bio-Rad EVP clinical diagnostics group president John Hertia in a prepared statement. “This addition rounds out our offering, specifically benefitting mid-and smaller volume laboratories using gel technology to test blood in an automated way.”
In February, a federal appeals court panel slashed dealt Bio-Rad’s former general counsel’s $11 million jury award by $6 million and sent his whistleblower retaliation lawsuit back to U.S. District Court for a possible new trial.
