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System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection

PFS · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.5900

Classification

FDA Product Code
PFS
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.5900
Review panel
PA
Medical specialty
Immunology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N

Definition

The CFTR gene variant detection system is used to sequence specified regions of the CFTR gene to detect gene variants. It is intended as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (CF), those with atypical or non-classic presentation of CF, or when other mutation panels have failed to identify both causative mutations. It is not intended for screening (carrier, newborn, population, or pre-implantation), prenatal diagnostic, or used for stand-alone diagnostic purposes

Market data

Cleared 510(k) submissions
1
Registered establishments
1

Source

Authoritative
FDA Device Classification database
Machine
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