Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010286073

FEI Number

3010286073

Entity Name

LIFE TECHNOLOGIES HOLDINGS PTE LTD

City/State/Country

Jurong West North West, SG

Establishment Address

7 Gul Circle, #2M-01/08, Keppel Logistics Building, Jurong West North West 629563, SG

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Life Technologies (Owner Number: 9066102)

Owner / Operator Contact Address

5781 Van Allen Way, --, Carlsbad, CA 92008, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CytoScan® Dx Assay 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	2007-11-28

Official Correspondent

Jody Schulz

US Agent Details

Jody Schulz Business: Jody Schulz Email: jody.schulz@thermofisher.com Phone: (414) 5344809

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
3003314809	AFFYMETRIX, INC.	Santa Clara, CA, US

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

Similar Registrations

Registration Number	Establishment Name	Location
3003314809	AFFYMETRIX, INC.	Santa Clara, CA, US
3009731198	Roche Diagnostics Santa Clara	Santa Clara, CA, US
2916205	Agilent Technologies, Inc	Santa Clara, CA, US
3009189893	Agilent Technologies Inc.	Cedar Creek, TX, US
3005370583	KORVIS LLC (DBA Ascential Medical & Life Sciences)	Corvallis, OR, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010286073. Last updated year: 2026. Please use registration number 3010286073 when referencing this establishment in official correspondence.