Device type
High Throughput Dna Sequence Analyzer
Product code PFF · Class II · 21 CFR 862.2265 · Immunology
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)s
No 510(k) clearances in the archive for PFF.
Recent recalls
Oct 30, 2026
Z-0321-2027
MiSeq Dx Instrument REF: DX-410-1001 / 15036706, FOR IN VITRO DIAGNOSTIC USE
Illumina, Inc.
- PFF
- Class II
- Open, Classified
Oct 30, 2026
Z-0323-2027
Illumina DRAGEN Server for NextSeq 550Dx REF: 20086130,
Illumina, Inc.
- PFF
- Class II
- Open, Classified
Oct 30, 2026
Z-0324-2027
VeriSeq Onsite Server V2 REF: 20047000
Illumina, Inc.
- PFF
- Class II
- Open, Classified
Oct 30, 2026
Z-0320-2027
Nextseq 550Dx Instrument REF: 20005715, FOR IN VITRO DIAGNOSTIC USE
Illumina, Inc.
- PFF
- Class II
- Open, Classified
Oct 30, 2026
Z-0322-2027
NovaSeq 6000Dx Instrument REF: 20068232, FOR IN VITRO DIAGNOSTIC USE
Illumina, Inc.
- PFF
- Class II
- Open, Classified
Oct 28, 2026
Z-0211-2027
Ion Torrent Genexus Dx with software, Catalog: A40003539, which supports the Ion Torrent Genexus Dx Integrated Sequencer
Life Technologies Holdings Pte Ltd
- PFF
- Class II
- Ongoing
Oct 7, 2026
Z-0068-2027
NovaSeq 6000Dx including DRAGEN Server, Catalog Number: 20068232; Illumina DRAGEN Server for NextSeq 550Dx, Catalog Number: 20086130
Illumina, Inc.
- PFF
- Class II
- Ongoing