High Throughput Dna Sequence Analyzer

PFF · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 862.2265

Classification

FDA Product Code: PFF
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 862.2265
Review panel: TX
Medical specialty: Immunology
Submission type: 4
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 10

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown