PFS

Product Code: PFS

Products Classified as PFS

4924

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

Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Gene Mutation Detection System.

Total Product Life Cycle (TPLC) Devices

4924

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

Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Gene Mutation Detection System.

FDA Consensus Standards

• System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection [33070]: 21 CFR §866.5900 🔎

Pre-market Notifications for PFS

K132750

ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY

ILLUMINA, INC.

Global Unique Device Identification Database

• 00816270020026: System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection
• 00816270020385: System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection
• 00816270020262: System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection