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FDA 510(k)

XTAG RESPIRATORY VIRAL PANEL

K-Number: K081483 · 2008-06-25

ApplicantLuminex Molecular Diagnostics, Inc.
Decision Date2008-06-25
Product CodeOCC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

XTAG RESPIRATORY VIRAL PANEL is the device name listed in this FDA 510(k) record. The listed applicant is Luminex Molecular Diagnostics, Inc.. It received FDA 510(k) clearance on 2008-06-25 under 510(k) number K081483. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XTAG RESPIRATORY VIRAL PANEL?

XTAG RESPIRATORY VIRAL PANEL is a medical device that received FDA 510(k) clearance on 2008-06-25. The listed applicant is Luminex Molecular Diagnostics, Inc.. The 510(k) number is K081483.

When did XTAG RESPIRATORY VIRAL PANEL receive FDA 510(k) clearance?

XTAG RESPIRATORY VIRAL PANEL received FDA 510(k) clearance on 2008-06-25, under 510(k) number K081483.

Who is the listed applicant for XTAG RESPIRATORY VIRAL PANEL?

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

What is the FDA product code for XTAG RESPIRATORY VIRAL PANEL?

The FDA product code for XTAG RESPIRATORY VIRAL PANEL is OCC.

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Other records listing Luminex Molecular Diagnostics, 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.

K242613NxTAG® Respiratory Pathogen PanelK231758NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)K193167NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT SoftwareK191161xTAG Gastrointestinal Pathogen Panel (GPP)K191160xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)K183023xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)

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Related Devices (Code: OCC)

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.

K262747ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0Abbott Diagnostics Scarborough, Inc.K254139BioCode® Respiratory Pathogen Panel (RPP)Applied BioCode, Inc.K242613NxTAG® Respiratory Pathogen PanelLuminex Molecular Diagnostics, Inc.K232775ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc.K231017Panther Fusion AdV/hMPV/RV AssayHologic, Inc.K213822cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.

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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