# Illumina, Inc.

FEI: 3003218906
Status: Active
Establishment types: Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device
Owner/operator: Illumina, Inc. (#10030352)

Address: 5200 Illumina Way, San Diego, CA, US



## Products

Total registered: 1
Top product codes: PFT
Regulation §: 862.3800

Proprietary names: DRAGEN™ for Illumina DNA Prep with Enrichment Dx Application for NextSeq 550Dx, Local Run Manager DNA GenerateFASTQ Dx Module for MiSeqDx, NovaSeq™ 6000Dx Library Tube, NovaSeq™ 6000Dx Library Tube, 24 pack, Illumina® DNA Prep with Enrichment Dx with UD Indexes Set B (16 samples), TruSeq™ Custom Amplicon Kit Dx- FFPE, MiSeq™Dx Reagent Kit V3, NovaSeq™ 6000Dx S4 Reagent v1.5 Kit (300 cycles), NovaSeq™ 6000Dx S4 Buffer Cartridge, NovaSeq™ 6000Dx S2 Reagent v1.5 Kit (300 cycles)

## Source

- openFDA: https://api.fda.gov/device/registrationlisting.json?search=registration.fei_number:%223003218906%22
- FDA Registration Lookup: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm?lid=3003218906