Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003218906

FEI Number

3003218906

Entity Name

Illumina, Inc.

City/State/Country

San Diego, CA, US

Establishment Address

5200 Illumina Way, San Diego, CA 92122, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device

Owner / Operator

Illumina, Inc. (Owner Number: 10030352)

Owner / Operator Contact Address

5200 Illumina Way, San Diego, CA 92122, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Local Run Manager CF Clinical Sequencing Analysis Module Local Run Manager CF Clinical Seq 2 Micro Analysis Module Local Run Manager CF 139-Variant 2 Micro Analysis Module Local Run Manager CF 139 Variant Analysis Module TruSight Oncology DNA Control TruSight Oncology RNA Control NextSeq 550Dx Instrument NovaSeq 6000Dx Instrument Illumina DRAGEN Server for NextSeq 550Dx

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PFS	System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection	Immunology	Class 2	866.5900	2014-01-10
PFR	System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection	Immunology	Class 2	866.5900	2014-01-10
SCU	Dna And Rna Oncology Controls	Microbiology	Class 2	866.5910	2024-11-07
PFF	High Throughput Dna Sequence Analyzer	Immunology	Class 2	862.2265	2017-12-04

Official Correspondent

Karen Gutekunst

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Illumina, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3006296346	Illumina, Inc. Hayward	Hayward, CA, US
3007102730	Illumina Singapore Pte. Ltd.	Singapore Central Singapore, SG

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3009875001	Vela Operations Singapore Pte Ltd	Singapore Central Singapore, SG
3007287152	LIFE TECHNOLOGIES CORPORATION	Carlsbad, CA, US
3007102730	Illumina Singapore Pte. Ltd.	Singapore Central Singapore, SG

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003218906. Last updated year: 2026. Please use registration number 3003218906 when referencing this establishment in official correspondence.