
Immucor Gti Diagnostics, Inc.
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PF4 Enhanced assay is an FDA 510(k)-cleared medical device (K201570) manufactured by Immucor Gti Diagnostics, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 10, 2020. Regulation: 8.