Company ยท US
Illumina, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2013. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
15recalls (7 in 12 months)
2recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| PFF | High Throughput Dna Sequence Analyzer | 13 |
| PFS | System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection | 3 |
| PFT | Reagents For Molecular Diagnostic Test Systems | 2 |
| NPQ | Test, Factor V Leiden Mutations, Genomic Dna Pcr | 1 |
| NSU | Instrumentation For Clinical Multiplex Test Systems | 1 |
| PFR | System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 19, 2013 | K132750 | ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY Illumina, Inc. | PFS |
| Nov 19, 2013 | K124006 | ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY Illumina, Inc. | PFR |
| Nov 19, 2013 | DEN130042 | MISEQDX UNIVERSAL KIT 1.0 Illumina, Inc. | PFT |
| Nov 19, 2013 | DEN130011 | ILLUMINA MISEQDX PLATFORM Illumina, Inc. | PFF |
| Apr 28, 2010 | K093129 | ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II Illumina, Inc. | NPQ |
| Apr 28, 2010 | K093128 | ILLUMINA BEADXPRESS SYSTEM Illumina, Inc. | NSU |
Latest recalls
| 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 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 |
| Dec 4, 2025 | Illumina, Inc. Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument:
NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 20028870/NextSeq 550Dx HO FC Cart v2.5, 75 Cycles, REF: 20 Open, Classified |
PFT | 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 |
| Dec 23, 2014 | Illumina Inc Illumina MiSeqDx Universal Kit 1.0, PN 15039608
The Illumina MiSeqDx Universal Kit 1.0 is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral Terminated |
PFS | K132750 |
| Dec 23, 2014 | Illumina Inc Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform. Terminated |
PFS | K132750 |
| 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 |