NUA · Class II · 21 CFR 866.5900

FDA Product Code NUA: System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection

The Cftr Gene Mutation Detection System Is A Device Used To Simultaneously Detect And Identify A Panel Of Mutations And Variants In The Cftr Gene. It Is Intended As An Aid In Confirmatory Diagnostic Testing Of Individuals With Suspected Cystic Fibrosis (cf), Carrier Identification, And Newborn Screening. This Device Is Not Intended For Stand-alone Diagnostic Purposes, Prenatal Diagnostic, Pre-implantation Or Population Screening.

12
Total
11
Cleared
186d
Avg days
2005
Since

FDA 510(k) Cleared System, Cystic Fibrosis Transmembrane Conductance Regulator, Gene Mutation Detection Devices (Product Code NUA)

12 devices
1–12 of 12
No devices found for this product code.

About Product Code NUA - Regulatory Context