PFF

High Throughput Dna Sequence Analyzer

Product code

PFF

Device name

High Throughput Dna Sequence Analyzer

Device class

Class 2

21 CFR

21 CFR 862.2265

Medical specialty

Immunology

Marketing pathway

510(K) Exempt

510(k) clearances (all years, FDA)

2 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).