
Stanbio Laboratory
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STANBIO SYPHILIS RPR TEST, NO. 1170 is an FDA 510(k)-cleared medical device (K880144) manufactured by Stanbio Laboratory. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 22, 1988. Regulation: 8.

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