510(k) K243343

BD CTGCTV2 by Bd Integrated Diagnostic Solutions/Becton, — Product Code QEP

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 22, 2025
Date Received: October 25, 2024
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections
Device Class: Class II
Regulation Number: 866.3393
Review Panel: MI
Submission Type

A device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections is an in vitro diagnostic device intended for the detection and identification of nucleic acids from non-viral microorganism(s) in clinical specimens collected from patients suspected of sexually transmitted infections. The device is intended to aid in the diagnosis of non-viral sexually transmitted infections in conjunction with other clinical and laboratory data.

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