
Xenotope Diagnostics, Inc.
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XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01 is an FDA 510(k)-cleared medical device (K020595) manufactured by Xenotope Diagnostics, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on February 19, 2003. Regulation: 8.