
T Cell Diagnostics, Inc.
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TRAX(TM) CD4 TEST KIT is an FDA 510(k)-cleared medical device (K925255) manufactured by T Cell 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 May 14, 1995. Regulation: 8.