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Medical Devices / Submissions and Approvals

FDA Clears Bio-Rad Blood Screener

April 10, 2019

The FDA granted 510(k) clearance to Bio-Rad Laboratories’ IH-500, a blood typing and screening device.

The automated device uses gel card technology and is intended for small- to medium-sized laboratories that need a blood tester that requires minimal user involvement.

The IH-500 can process the company’s entire product line of IH gel cards for blood grouping, antibody screening and antigen testing.

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