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 a medical device manufactured by Neumodx Molecular, Inc.. It received FDA 510(k) clearance on 2023-12-22 under approval 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. It is manufactured by Neumodx Molecular, Inc.. The 510(k) number is K230267.
When was NeuMoDx CT/NG Assay 2.0 approved by the FDA?
NeuMoDx CT/NG Assay 2.0 received FDA 510(k) clearance on 2023-12-22, under approval number K230267.
What company makes NeuMoDx CT/NG Assay 2.0?
NeuMoDx CT/NG Assay 2.0 is manufactured by Neumodx Molecular, Inc..
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.
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Official Source
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