XTAG Gastrointestinal Pathogen Panel (GPP), XTAG Data Analysis Software (TDAS GPP)

Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System

Luminex Molecular Diagnostics, Inc.

The following data is part of a premarket notification filed by Luminex Molecular Diagnostics, Inc. with the FDA for Xtag Gastrointestinal Pathogen Panel (gpp), Xtag Data Analysis Software (tdas Gpp).

Pre-market Notification Details

Device IDK191160
501k NumberK191160
Device Name:XTAG Gastrointestinal Pathogen Panel (GPP), XTAG Data Analysis Software (TDAS GPP)
ClassificationGastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System
Applicant Luminex Molecular Diagnostics, Inc. 439 University Avenue Toronto,  CA M5g 1y8
ContactTina Ip
CorrespondentTina Ip
Luminex Molecular Diagnostics, Inc. 439 University Avenue Toronto,  CA M5g 1y8
Product CodePCH  
CFR Regulation Number866.3990 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyMicrobiology
501k Review PanelMicrobiology
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-01
Decision Date2019-11-04

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