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FDA 510(k)

NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)

K-Number: K231758 · 2024-03-11

ApplicantLuminex Molecular Diagnostics, Inc.
Decision Date2024-03-11
Product CodeQOF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) is a medical device manufactured by Luminex Molecular Diagnostics, Inc.. It received FDA 510(k) clearance on 2024-03-11 under approval number K231758. The device is classified under product code QOF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)?

NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) is a medical device that received FDA 510(k) clearance on 2024-03-11. It is manufactured by Luminex Molecular Diagnostics, Inc.. The 510(k) number is K231758.

When was NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) approved by the FDA?

NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) received FDA 510(k) clearance on 2024-03-11, under approval number K231758.

What company makes NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)?

NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) is manufactured by Luminex Molecular Diagnostics, Inc..

What is the FDA product code for NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)?

The FDA product code for NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) is QOF.

Other Devices by Luminex Molecular Diagnostics, Inc.

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Official Source

View on FDA Database →

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

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