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Siemens Healthcare Diagnostics
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IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM is an FDA 510(k)-cleared medical device (K091361) manufactured by Siemens Healthcare Diagnostics. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 15, 2009. Regulation: 8.