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510(k) DEN110012

APTIMA TRICHOMONAS VAGINALIS ASSAY by Gen-Probe Incorporated — Product Code OUY

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
April 19, 2011
Date Received
April 13, 2011
Clearance Type
Post-NSE
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Trichomonas Vaginalis Nucleic Acid Amplification Test System
Device Class
Class II
Regulation Number
866.3860
Review Panel
MI
Submission Type

In vitro nucleic acid amplification test for the qualitative detection of ribosomal rna from trichomonas vaginalis as an aid in the diagnosis of trichomoniasis from vaginal, cervical, urogenital and gynecological specimens from symptomatic patients

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