Luminex Molecular Diagnostics, Inc

FDA Filings

This page includes the latest FDA filings for Luminex Molecular Diagnostics, Inc. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
Luminex Molecular Diagnostics, Inc.
XTAG Gastrointestinal Pathogen Panel (GPP)2019-11-12
Luminex Molecular Diagnostics, Inc.
XTAG Gastrointestinal Pathogen Panel (GPP), XTAG Data Analysis Software (TDAS GPP)2019-11-04
Luminex Molecular Diagnostics, Inc.
XTAG Gastrointestinal Pathogen Panel (GPP), XTAG Data Analysis Software (TDAS GPP)2018-11-30
Luminex Molecular Diagnostics, Inc.
XTAG Gastrointestinal Pathogen Panel (GPP), XTAG Data Analysis Software (TDAS GPP)2018-11-30
Luminex Molecular Diagnostics, Inc.
XTAG Cystic Fibrosis 39 Kit V22016-12-15
Luminex Molecular Diagnostics, Inc.
XTAG Cystic Fibrosis 60 Kit V2, XTAG Data Analysis Software (TDAS) CFTR2016-12-15

Latest Premarket Applications

PMAManufacturerDevice NameDate

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
xTAG® Gastrointestinal Pathogen Panel (GPP)
Luminex Molecular Diagnostics, Inc2019-11-26
xTAG® Cystic Fibrosis (CFTR) 39 kit v2
Luminex Molecular Diagnostics, Inc2019-10-28

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