Illumina, Inc. Hayward

FDA Device Registration & Listing · Hayward, CA, US · Registration 3006296346

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006296346
FEI Number
3005095756
Entity Name
Illumina, Inc. Hayward
City/State/Country
Hayward, CA, US
Establishment Address
25841 Industrial Blvd, Hayward, CA 94545, US
Establishment Type(s)
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
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

MiSeq™Dx China MiSeq™Dx 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
PFF High Throughput Dna Sequence Analyzer Immunology Class 2 862.2265 2014-01-10
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
3007102730 Illumina Singapore Pte. Ltd. Singapore Central Singapore, SG
3003218906 Illumina, Inc. San Diego, CA, US

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006296346. Last updated year: 2026. Please use registration number 3006296346 when referencing this establishment in official correspondence.
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