DeviceClearance

Product code PFF— Immunology

ILLUMINA MISEQDX PLATFORM

Classification name
High Throughput Dna Sequence Analyzer
Device class
Class 2
Regulation
21 CFR 862.2265
Advisory panel
Immunology
Total cleared
2
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code PFF under 21 CFR 862.2265, via openFDA

Market context for product code PFF

FDA has cleared 2 devices under product code PFF between 2013 and 2017, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PFF

Recent clearances under product code PFF

Data sourced from openFDA. This site is unofficial and independent of the FDA.