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Medical Devices / Submissions and Approvals

Bio-Rad Gains Additional FDA Clearances for Blood Typing Products

Jan. 29, 2018
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Bio-Rad Laboratories received 510(k) clearance from the FDA for its IH-Incubator L and IH-Centrifuge L instruments for use with the full range of Bio-Rad’s IH-system gel reagents for manual blood typing methods.

The instruments maximize efficiency and space in the laboratory by accommodating both conventional tube and gel blood typing.

“This addition rounds out our offering, specifically benefitting smaller laboratories that use manual methods to test blood,” said John Hertia, Bio-Rad’s executive vice president and president of the company’s clinical diagnostics group.

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