AFFYMETRIX, INC.

FDA Device Registration & Listing · Santa Clara, CA, US · Registration 3003314809

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
3003314809
FEI Number
3003314809
Entity Name
AFFYMETRIX, INC.
City/State/Country
Santa Clara, CA, US
Establishment Address
3450 Central Expy, Santa Clara, CA 95051, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Life Technologies (Owner Number: 9066102)
Owner / Operator Contact Address
5781 Van Allen Way, --, Carlsbad, CA 92008, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
DEN040012
PMA Number
N/A

All Registered Proprietary Names

CytoScan® Dx Assay Concerto Imager GeneChip System 3000Dx v.2

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PFX System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection Immunology Class 2 866.5920 2014-05-26
NSU Instrumentation For Clinical Multiplex Test Systems Clinical Chemistry Class 2 862.2570 2017-12-20
NSU Instrumentation For Clinical Multiplex Test Systems Clinical Chemistry Class 2 862.2570 2007-11-28

Official Correspondent

Jody Schulz

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Life Technologies
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3010286073 LIFE TECHNOLOGIES HOLDINGS PTE LTD Jurong West North West, SG

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0027-2018 Hologic, Inc 2
Panther(R) System, Catalog Number 902615, For Use with Hologic Assays, For In Vitro Diagnostic Use

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Registration Number Establishment Name Location
3010286073 LIFE TECHNOLOGIES HOLDINGS PTE LTD Jurong West North West, SG
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003314809. Last updated year: 2026. Please use registration number 3003314809 when referencing this establishment in official correspondence.
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