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Luminex Molecular Diagnostics, Inc.

FDA 510(k) & PMA Approved Devices — 10 products

Total Devices10
Categories5
Latest FDA decision2024-10-02
TypeNumberDevice NameCodeDateActions
510(k) K242613 NxTAG® Respiratory Pathogen PanelOCC2024-10-02 View
510(k) K231758 NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2)QOF2024-03-11 View
510(k) K193167 NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT SoftwareOCC2019-12-11 View
510(k) K191161 xTAG Gastrointestinal Pathogen Panel (GPP)PCH2019-11-12 View
510(k) K191160 xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)PCH2019-11-04 View
510(k) K183030 xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)PCH2018-11-30 View
510(k) K183023 xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)PCH2018-11-30 View
510(k) K170492 xTAG CYP2D6 Kit v3NTI2017-08-11 View
510(k) K163347 xTAG Cystic Fibrosis 39 Kit v2NUA2016-12-15 View
510(k) K163336 xTAG Cystic Fibrosis 60 Kit v2, xTAG Data Analysis Software (TDAS) CFTRNUA2016-12-15 View
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