Product code PFF

Device name

High Throughput Dna Sequence Analyzer

Medical specialty

Immunology

Device class

2

Regulation number

862.2265

Review panel

TX

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset