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Illumina, Inc.

United States·US-MF-000013476

Last updated September 17, 2026

Information

Country: United States
Address: 5200 Illumina Way, San Diego, United States
Website: www.illumina.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 800-809-4566
PRRC Contact: Giavonna Goodman
EUDAMED SRN: US-MF-000013476
FDA FEI Number: 3003218906
DUNS Number: 033305264

Catalogue (52)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Local Run Manager CF Clinical Seq 2.0 Micro Analysis Module	20072974	FDA UDI	Class II	Active
Praxis Extended RAS Panel	20012431	FDA UDI	Class III	Unknown
MiSeqDx CF 139 Variant Assay (2 Run)	15036580	FDA UDI	Class II	Unknown
NovaSeq™ 6000Dx Library Tube, 24 pack	20062291	FDA UDI	Class I	Active
TruSight™ Oncology DNA Control IVD	20065041	FDA UDI	Class II	Active
Local Run Manager CF 139 Variant Analysis Module	20047009	FDA UDI	Class II	Active
MiSeqDx Reagent Kit v3	20012552	FDA UDI	Class I	Unknown
MiSeqDx Universal Kit 1.0	15038741	FDA UDI	Class I	Unknown
MiSeqDx Cystic Fibrosis 139 Variant Assay (20 Run)	15036577	FDA UDI	N/A	Unknown
TruSeq Custom Amplicon Kit Dx - FFPE QC	20006259	FDA UDI	Class I	Active
MiSeqDx Cystic Fibrosis Clinical Sequencing Assay (6 Run)	15036620	FDA UDI	Class II	Unknown
TruSight™ Oncology Comprehensive	20032573	FDA UDI	Class III	Active
DRAGEN™ for Illumina® DNA Prep with Enrichment Dx for NovaSeq™ 6000Dx	20074609	FDA UDI	Class I	Active
TruSight™ Oncology RNA Control	20065042	FDA UDI	Class II	Active
MiSeq™ Dx (China)	20014053	FDA UDI	Class II	Active
NovaSeq™ 6000Dx Library Tube	20062290	FDA UDI	Class I	Active
TruSight™ Cystic Fibrosis Library Preparation	20036925	FDA UDI	Class I	Unknown
Local Run Manager CF Clinical Sequencing Analysis Module	20046734	FDA UDI	Class II	Active
NovaSeq™ 6000Dx S2 Buffer Cartridge	20062292	FDA UDI	Class I	Active
NovaSeq™ 6000Dx S4 Buffer Cartridge	20062293	FDA UDI	Class I	Active
NextSeq550Dx Reagent Kit v2(300 cyc) IVD	20019554	FDA UDI	Class I	Unknown
Local Run Manager CF 139-Variant 2.0 Micro Analysis Module	20072975	FDA UDI	Class II	Active
Local Run Manager DNA GenerateFASTQ Dx Module for NextSeq™ 550Dx	20063024	FDA UDI	Class I	Active
TruSeq Custom Amplicon Kit Dx	20005718	FDA UDI	Class I	Active
NovaSeq™ 6000Dx Instrument	20068232	EUDAMEDFDA UDI	Class A	Active
NextSeq™ 550Dx High Output Reagent Kit v2.5 (75 cycles)	20028870	EUDAMEDFDA UDI	Class A	Active
NextSeq™ 550Dx High Output Reagent Kit v2.5 (300 cycles)	20028871	EUDAMEDFDA UDI	Class A	Active
Illumina Miseqdx Cystic Fibrosis 139-Variant Assay	K124006	FDA 510(k)	Class II	Active
Illumina Miseqdx Cystic Fibrosis Clinical Sequencing Assay	K132750	FDA 510(k)	Class II	Active
Miseqdx Universal Kit 1.0	DEN130042	FDA 510(k)	Class I	Active
Illumina Miseqdx Platform	DEN130011	FDA 510(k)	Class II	Active
Illumina Verncode Genotyping Test For Facor V And Factor Ii	K093129	FDA 510(k)	Class II	Active
Illumina Beadxpress System	K093128	FDA 510(k)	Class II	Active
MiSeq™Dx Instrument	DX-410-1001	EUDAMEDFDA UDI	Class A	Active
MiSeq™Dx Reagent Kit v3 Micro	20063860	EUDAMEDFDA UDI	Class A	Active
Illumina® DNA Prep with Enrichment Dx with UD Indexes Set A (16 samples)	20051354	EUDAMEDFDA UDI	Class A	Active
VeriSeq™ NIPT Sample Preparation Kit (48 samples)	15066801	EUDAMED	Class C	Active
MiSeq™Dx Reagent Kit v3	20037124	EUDAMEDFDA UDI	Class A	Active
VeriSeq™ NIPT Sample Preparation Kit (24 samples)	20025895	EUDAMED	Class C	Active
TruSight™ Oncology Comprehensive (EU) kit	20063092	EUDAMED	IVD General	Active
llumina® DNA Prep with Enrichment Dx with UD Indexes Set A (96 samples)	20051352	EUDAMEDFDA UDI	Class A	Active
VeriSeq™ NIPT Sample Preparation Kit (96 samples)	15066802	EUDAMED	Class C	Active
Local Run Manager DNA GenerateFASTQ Dx Module for MiSeqDx	20063022	EUDAMEDFDA UDI	Class A	Active
Illumina® DNA Prep with Enrichment Dx with UD Indexes Set B (96 Samples)	20051353	EUDAMEDFDA UDI	Class A	Active
NovaSeq 6000Dx S2 Reagent v1.5 Kit (300 cycles)	20046931	EUDAMEDFDA UDI	Class A	Active
VeriSeq™ NIPT Workflow Manager v2	20044988	EUDAMED	Class A	Active
Illumina® DNA Prep with Enrichment Dx with UD Indexes Set B (16 samples)	20051355	EUDAMEDFDA UDI	Class A	Active
Local Run Manager VeriSeq™ NIPT module	20044989	EUDAMED	Class A	Active
TruSight Oncology Comprehensive	P230011	FDA PMA	Class III	Active
Praxis Extended RAS Panel	P160038	FDA PMA	Class III	Active

Related Companies

Authorised Representatives

Illumina Netherlands B.V. NL

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FDA Recalls (9)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Oct 28, 2025	Z-0884-2026	—	open, classified	An instrument intended for sequencing DNA libraries with in vitro diagnostic assays is used with reagent kits including flow cells that have flow cell gaskets that have a quality issue, which may lead to flow cell leaks during runs, which could cause run failures, that may result in: No/insufficient data output, instrument fluidics clogs, toxic substance exposure to user.
Apr 5, 2023	Z-1976-2023	—	completed	Cybersecurity vulnerability concerning the software used for sequencing instruments.
Apr 5, 2023	Z-1977-2023	—	completed	Cybersecurity vulnerability concerning the software used for sequencing instruments.
May 3, 2022	Z-1260-2022	—	completed	cybersecurity vulnerability
May 3, 2022	Z-1259-2022	—	completed	cybersecurity vulnerability
Feb 22, 2022	Z-0854-2022	—	completed	There is a potential that the DNA sequence analyzer may short circuit shortly after disconnection and reconnection of circuit board or imaging module due to an insufficient reconnection of the ribbon cable. The short circuit results in the device being inoperable.
Nov 13, 2014	Z-0849-2015	—	terminated	It was discovered a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Universal Kit 1.0 on the MiSeqDx instrument. The software cannot report insertions or deletions at specific genomic locations with respect to the primer.
Nov 6, 2014	Z-0850-2015	—	terminated	Illumina has confirmed a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Cystic Fibrosis Clinical Sequencing Assay on the MiSeqDx instrument.
Jul 28, 2014	Z-2611-2014	—	terminated	A software component of the MiSeqDx instrument, called the Illumina Worklist Manager (IWM) v1.0.15, fails to perform as intended