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System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection

FDA product code NUA · Class 2 · Immunology

3
Registered devices
5
Adverse events
2
Recalls
12
510(k) clearances

Devices with this code

xTAG® Cystic Fibrosis (CFTR) 60 kit v2 — Luminex Molecular Diagnostics, IncxTAG® Cystic Fibrosis Mutation Detection Kit — Luminex Molecular Diagnostics, IncxTAG® Cystic Fibrosis (CFTR) 39 kit v2 — Luminex Molecular Diagnostics, Inc

Recent recalls

DateFirmReason
2016-03-31Hologic, IncComplaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive testing during pregnancy and the associated risks of such invas
2016-03-31Hologic, IncComplaints of false positive HET mutations and leaking cards; could lead to unnecessary invasive testing during pregnancy and the associated risks of such invas

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.