510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PFRClass II

System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection

21 CFR 866.5900 / Immunology
FDA source (opens on fda.gov)

PFR is the FDA product code for System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection, a class II device type, regulated under 21 CFR 866.5900. FDA's definition for this code reads: "The CFTR gene mutation detection system is used to simultaneously detect and identify a specified panel of mutations and variants in the CFTR gene using sequencing methods. It is intended for carrier screening, as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (CF), and as an...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
PFR
Device name
System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection
FDA definition
The CFTR gene mutation detection system is used to simultaneously detect and identify a specified panel of mutations and variants in the CFTR gene using sequencing methods. It is intended for carrier screening, as an aid in confirmatory diagnostic testing of individuals with suspected cystic fibrosis (CF), and as an initial test to aid in the diagnosis of individuals with suspected CF. It is not intended for stand-alone diagnostic purposes, prenatal diagnostic, or pre-implantation screening.
Regulation
21 CFR 866.5900
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code PFR

By decision year
1 clearance under product code PFR with a decision year between 2013 and 2013, 2013 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PFR by decision year
YearClearances
20131

Applicants with the most clearances

Product code PFR
Applicants holding the most 510(k) clearances under product code PFR
ApplicantClearances
Illumina, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code