K-number	DEN110012
Device name	APTIMA TRICHOMONAS VAGINALIS ASSAY
Applicant	Gen-Probe Incorporated
Product code	OUY
Device class	Class II
Decision date	Apr 19, 2011
Decision	Not Substantially Equivalent
Regulation	866.3860

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View the full FDA submission: accessdata.fda.gov

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APTIMA TRICHOMONAS VAGINALIS ASSAY

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