4 results
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52ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identification of multiple viral, bacterial and parasitic nucleic acids in human stool specimens or human stool (GPP) Kit, IVD, REF I032C0316.
FDA Enforcement
Class II
·Ongoing·Luminex Molecular Diagnostics·June 19, 2019
xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111 in vitro diagnostic test
FDA Enforcement
Class II
·Ongoing·Luminex Molecular Diagnostics·October 30, 2019
NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
FDA Enforcement
Class II
·Ongoing·Luminex Molecular Diagnostics Inc·October 16, 2024
NxTAG Respiratory Pathogen Panel, REF: I051C0447
FDA Enforcement
Class II
·Ongoing·Luminex Molecular Diagnostics Inc·October 16, 2024