
Praxsys Biosystems, Inc.
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PRAXSYS RELIA TSH TEST is an FDA 510(k)-cleared medical device (K011527) manufactured by Praxsys Biosystems, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 6, 2001. Regulation: 8.