
Behring Diagnostics, Inc.
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ENAII TEST KIT(SS-A(RO) & SS-B(LA) AUTOANTIBODY is an FDA 510(k)-cleared medical device (K843978) manufactured by Behring Diagnostics, 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 December 17, 1984. Regulation: 8.