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510(k) K230267

NeuMoDx CT/NG Assay 2.0 by Neumodx Molecular, Inc. — Product Code QEP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2023
Date Received
January 31, 2023
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.

Other clearances by Neumodx Molecular, Inc.

  • K173725 — NeuMoDx GBS Assay (June 26, 2018)

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  • K222379 — Alinity m STI Assay (March 3, 2023)
  • K220321 — Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) (June 3, 2022)
  • K210585 — BD CTGCTV2 (May 10, 2022)
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  • K193081 — Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and soft (December 17, 2021)