Panels › Immunology › Product code PFF · Class 2
High Throughput Dna Sequence Analyzer
Regulation 862.2265
0510(k)s in 12 months (2 all time)
7recalls in 12 months (18 all time)
4recalls that name a 510(k)
Top companies in PFF
| Company | 510(k)s | Recalls |
|---|---|---|
| Illumina, Inc. | 1 | 12 |
| Life Technologies Holdings Pte Ltd | 0 | 5 |
| Life Technologies Corporation | 1 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 30, 2026 | Illumina, Inc. VeriSeq Onsite Server V2
REF: 20047000 Open, Classified |
PFF | None listed |
| Oct 30, 2026 | Illumina, Inc. Illumina DRAGEN Server for NextSeq 550Dx
REF: 20086130, Open, Classified |
PFF | None listed |
| Oct 30, 2026 | Illumina, Inc. NovaSeq 6000Dx Instrument
REF: 20068232, FOR IN VITRO DIAGNOSTIC USE Open, Classified |
PFF | None listed |
| Oct 30, 2026 | Illumina, Inc. MiSeq Dx Instrument
REF: DX-410-1001 / 15036706, FOR IN VITRO DIAGNOSTIC USE Open, Classified |
PFF | None listed |
| Oct 30, 2026 | Illumina, Inc. Nextseq 550Dx Instrument
REF: 20005715, FOR IN VITRO DIAGNOSTIC USE Open, Classified |
PFF | None listed |
| Oct 22, 2026 | Life Technologies Holdings Pte Ltd Ion Torrent Genexus Dx with software, Catalog: A40003539, which supports the Ion Torrent Genexus Dx Integrated Sequencer Open, Classified |
PFF | None listed |
| Oct 1, 2026 | Illumina, Inc. NovaSeq 6000Dx including DRAGEN Server, Catalog Number: 20068232;
Illumina DRAGEN Server for NextSeq 550Dx, Catalog Number: 20086130 Open, Classified |
PFF | None listed |
| Mar 29, 2024 | Life Technologies Corporation Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD intended for targeted sequencing of human genomic DNA (gDNA) from peripheral whole-blood samples and Open, Classified |
PFF | None listed |
| Jun 16, 2023 | Illumina, Inc. MiSeq Dx Instrument, Catalog # M70101, containing Universal Copy Service (UCS) software. Completed |
PFF | None listed |
| Jun 16, 2023 | Illumina, Inc. NextSeq 550Dx Instrument, Catalog # 20005715, contaning Universal Copy Service software Completed |
PFF | None listed |
| May 3, 2022 | Illumina, Inc. illumina Model NextSeq 550 Dx REF 20005715 Completed |
PFF | None listed |
| May 3, 2022 | Illumina, Inc. illumina REF DX-410-1001 Model: MiSeq Dx
illumina REF 15036706 Model: MiSeq Dx
illumina REF 20014053 Model: MiSeq Dx Completed |
PFF | None listed |
| Feb 22, 2022 | Illumina, Inc. Illumina NextSeq 550Dx, REF: 20005715, CE, IVD Completed |
PFF | None listed |
| Sep 26, 2019 | Life Technologies Holdings Pte Ltd Torrent Suite Dx Software Version 5.8
Catalog Number:A36601 and A36602
OEM Customer software: Torrent Suite Dx T430 Software v5.0 DARUI DR-SEQ 800 Software
UDI:(01)10190302014090 (11)000000(10)5.8 (2 Terminated |
PFF | K170299 |
| Sep 26, 2019 | Life Technologies Holdings Pte Ltd Torrent Suite Dx Software Version 5.6.4
Catalog Number:A33178
OEM Customer software: Sentosa SQ Suite Software v5.6.20
UDI: (01)10190302005654 (11)000000 (10)5.6.4 (240)A33178 Terminated |
PFF | K170299 |
| Sep 26, 2019 | Life Technologies Holdings Pte Ltd Torrent Suite Dx Software Version (IUO) 5.4
Catalog Number: A31774
OEM Customer Software: Sentosa SQ Suite Software v5.6.15 Terminated |
PFF | K170299 |
| Sep 26, 2019 | Life Technologies Holdings Pte Ltd Torrent Suite Dx Software Version (IUO) 5.2
Catalog Number: A29225
OEM Customer Software: Sentosa SQ Suite Software v5.6.9 Terminated |
PFF | K170299 |
| Sep 9, 2014 | Illumina Inc Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform.
Product Usage: The Illumina MiSeqDx is a sequencing instrument that measures fluorescence signals of labe Terminated |
PFF | None listed |
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