510(k) K243725

BD Vaginal Panel by Becton, Dickinson and Company — Product Code PQA

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 19, 2024
Date Received: December 3, 2024
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
Device Class: Class II
Regulation Number: 866.3975
Review Panel: MI
Submission Type

A vaginitis and bacterial vaginosis nucleic acid detection system is a qualitative in vitro diagnostic device for the direct detection of nucleic acid sequences from microorganisms associated with vaginitis or bacterial vaginosis. The device is indicated for individuals with signs and symptoms of vaginitis or bacterial vaginosis and aids in the diagnosis of these vaginal infections.

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Other clearances for product code PQA

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