
Grifols USA, Inc.
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EU-TTG IGA AND EU-TTG IGG is an FDA 510(k)-cleared medical device (K102964) manufactured by Grifols USA, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 6, 2011. Regulation: 8.