
Grifols USA, LLC
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INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT is an FDA 510(k)-cleared medical device (K120169) manufactured by Grifols USA, LLC. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 23, 2012. Regulation: 8.