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FDA 510(k)

NeuMoDx CT/NG Assay 2.0

K-Number: K230267 · 2023-12-22

ApplicantNeumodx Molecular, Inc.
Decision Date2023-12-22
Product CodeQEP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

NeuMoDx CT/NG Assay 2.0 is the device name listed in this FDA 510(k) record. The listed applicant is Neumodx Molecular, Inc.. It received FDA 510(k) clearance on 2023-12-22 under 510(k) number K230267. The device is classified under product code QEP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NeuMoDx CT/NG Assay 2.0?

NeuMoDx CT/NG Assay 2.0 is a medical device that received FDA 510(k) clearance on 2023-12-22. The listed applicant is Neumodx Molecular, Inc.. The 510(k) number is K230267.

When did NeuMoDx CT/NG Assay 2.0 receive FDA 510(k) clearance?

NeuMoDx CT/NG Assay 2.0 received FDA 510(k) clearance on 2023-12-22, under 510(k) number K230267.

Who is the listed applicant for NeuMoDx CT/NG Assay 2.0?

The FDA 510(k) record lists Neumodx Molecular, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NeuMoDx CT/NG Assay 2.0?

The FDA product code for NeuMoDx CT/NG Assay 2.0 is QEP.

Other records listing Neumodx Molecular, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K173725NeuMoDx GBS Assay

Related Devices (Code: QEP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260917cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systemsRoche Molecular Systems, Inc.K253759cobas liat CT/NG/MG nucleic acid testRoche Molecular Systems, Inc.K253756cobas liat CT/NG nucleic acid testRoche Molecular Systems, Inc.K251501Visby Medical Men's Sexual Health TestVisby Medical, Inc.K243343BD CTGCTV2Bd Integrated Diagnostic Solutions/Becton,K240217cobas® liat CT/NG nucleic acid testRoche Molecular Systems, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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