FDA 510(k)

NxTAG® Respiratory Pathogen Panel

N.º K: K242613 · 2024-10-02

SolicitanteLuminex Molecular Diagnostics, Inc.

Fecha de decisión2024-10-02

Código de productoOCC

Comité asesorMI

DecisiónSubstantially Equivalent

Resumen del dispositivo

NxTAG® Respiratory Pathogen 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 2024-10-02 under 510(k) number K242613. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the NxTAG® Respiratory Pathogen Panel?

NxTAG® Respiratory Pathogen Panel is a medical device that received FDA 510(k) clearance on 2024-10-02. The listed applicant is Luminex Molecular Diagnostics, Inc.. The 510(k) number is K242613.

When did NxTAG® Respiratory Pathogen Panel receive FDA 510(k) clearance?

NxTAG® Respiratory Pathogen Panel received FDA 510(k) clearance on 2024-10-02, under 510(k) number K242613.

Who is the listed applicant for NxTAG® Respiratory Pathogen 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 NxTAG® Respiratory Pathogen Panel?

The FDA product code for NxTAG® Respiratory Pathogen Panel is OCC.

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Otros registros que enlistan a Luminex Molecular Diagnostics, Inc. como solicitante

K231758NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)K193167NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software K191161xTAG Gastrointestinal Pathogen Panel (GPP)K191160xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)K183030xTAG 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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Dispositivos relacionados (Código: OCC)

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.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.K210234cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.

Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.