Device typeCystic fibrosis IVD, kit, multiplex: A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict one or multiple mutations associated with the inborn genetic disorder cystic fibrosis due to mutation in the cystic fibrosis conductance regulator (CFTR) gene, using a multiplex method.
FDA categorySystem, cystic fibrosis transmembrane conductance regulator, gene mutation detection
Device ID00840487100479
Catalog numberI024C0181
AvailabilityPrescription
MRI safetyLabeling does not contain MRI Safety Information