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Hellen Professional Services
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XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02 & S1383.03 is an FDA 510(k)-cleared medical device (K020226) manufactured by Hellen Professional Services. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 21, 2002. Regulation: 8.