Illumina, Inc.

SRN US-MF-000013476

manufacturer · San Diego, US · 38 devices

5200 Illumina Way, CA 92122

Devices

Name	UDI-DI	Class	Badge
DRAGEN® for Illumina DNA Prep with Enrichment Dx Application for NextSeq 550Dx	00816270020330	Class A	No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED
DRAGEN® for Illumina™ Prep with Enrichment Dx for NovaSeq 6000Dx	00816270020743	Class A	No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED
Illumina Connected Run TruSight™ Oncology Comprehensive HRD (EU, DRAGEN) Analysis Module	00816270020897	Class C	No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED
Illumina® DNA Prep with Enrichment Dx with UD Indexes Set A (16 samples)	00816270020477	Class A	No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED
Illumina® DNA Prep with Enrichment Dx with UD Indexes Set B (16 samples)	00816270020484	Class A	No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED
Illumina® DNA Prep with Enrichment Dx with UD Indexes Set B (96 Samples)	00816270020460	Class A	No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED
Illumina DRAGEN® Server for NextSeq550Dx	00816270020811	Class A	No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED
iScan™Dx	00816270020682	Class A	No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED
llumina® DNA Prep with Enrichment Dx with UD Indexes Set A (96 samples)	00816270020453	Class A	No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED
Local Run Manager DNA GenerateFASTQ Dx Module for MiSeqDx	00816270020392	Class A	No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED
Local Run Manager TruSight Oncology Comprehensive (EU) Analysis Module	00816270020309	Unknown class	No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED
Local Run Manager VeriSeq™ NIPT module	00816270020255	Class A	No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED
MiSeq™Dx Instrument	00816270020002	Class A	No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED
MiSeq™Dx Reagent Kit v3	00816270020156	Class A	No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED
MiSeq™Dx Reagent Kit v3 Micro	00816270020668	Class A	No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED
NextSeq™ 550Dx High Output Reagent Kit v2.5 (300 cycles)	00816270020118	Class A	No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED
NextSeq™ 550Dx High Output Reagent Kit v2.5 (75 cycles)	00816270020132	Class A	No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED
NextSeq™ 550Dx Instrument	00816270020125	Class A	No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED
NovaSeq 6000Dx S2 Reagent v1.5 Kit (300 cycles)	00816270020538	Class A	No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED
NovaSeq™ 6000Dx Instrument	00816270020637	Class A	No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED
NovaSeq™ 6000Dx Library Tube	00816270020552	Class A	No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED
NovaSeq™ 6000Dx Library Tubes, 24 Pk	00816270020583	Class A	No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED
NovaSeq™ 6000Dx S2 Buffer Cartridge	00816270020545	Class A	No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED
NovaSeq™ 6000Dx S4 Buffer Cartridge	00816270020576	Class A	No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED
NovaSeq™ 6000Dx S4 Reagent v1.5 Kit (300 cycles)	00816270020569	Class A	No Certificate Found Snapshot 2026-10-27 · Link to EUDAMED