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

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

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

PFS is the FDA product code for System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection, a class II device type, regulated under 21 CFR 866.5900. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and 2 recalls.

Classification record

Product code
PFS
Device name
System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection
FDA 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
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
2

Clearances, product code PFS

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

Applicants with the most clearances

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

Companies listing this code with FDA

Companies whose registered establishments list this code