PFF — High Throughput Dna Sequence Analyzer Class II

FDA Device Classification

Classification Details

Product Code
PFF
Device Class
Class II
Regulation Number
862.2265
Submission Type
Review Panel
TX
Medical Specialty
Immunology
Implant
No

Definition

A high throughput sequencing technology performing targeted DNA sequencing of amplicons from a defined genetic region or a subset of genes in human genomic DNA from a clinical sample.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K170299life technologies corporationIon PGM Dx SystemJune 22, 2017
DEN130011illuminaILLUMINA MISEQDX PLATFORMNovember 19, 2013