Life Technologies

FDA Filings

This page includes the latest FDA filings for Life Technologies. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Life Technologies holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• Kelli Tanzella
• LIFE TECHNOLOGIES HOLDINGS PTE LTD

FDA Registration(s)

• Registration Number: 3010286073
• FEI Number: 3010286073
• Name: LIFE TECHNOLOGIES HOLDINGS PTE LTD
• Owner & Operator: Life Technologies
• Contact Address: 5781 Van Allen Way --; Carlsbad CA 92008 US
• Official Correspondent:
  • Kelli Tanzella
  • x-716-7743122-x
• US Agent:
  • KellI Tanzella
  • Life Technologies
  • 716 7743122
  • kelli.tanzella@thermofisher.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 7 Gul Circle, #2M-01/08 Keppel Logistics Building; Jurong West North West, 629563 SG
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 3003314809
• FEI Number: 3003314809
• Name: AFFYMETRIX, INC.
• Owner & Operator: Life Technologies
• Contact Address: 5781 Van Allen Way --; Carlsbad CA 92008 US
• Official Correspondent:
  • Kelli Tanzella
  • x-716-7743122-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 3450 Central Expressway ; Santa Clara, CA 95051 US
• Establishment Type:
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Device in the United States for Export Only

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
NSU AFFYMETRIX, INC. [Life Technologies]	Concerto Imager	2017-12-20
PMN DEN130018 | PFX LIFE TECHNOLOGIES HOLDINGS PTE LTD [Life Technologies]	CytoScan? Dx Assay	2014-05-26
PMN DEN130018 | PFX AFFYMETRIX, INC. [Life Technologies]	CytoScan? Dx Assay	2014-05-26
PMN DEN040012 | NSU LIFE TECHNOLOGIES HOLDINGS PTE LTD [Life Technologies]	GeneChip System 3000Dx v.2	2007-11-28
PMN DEN040012 | NSU AFFYMETRIX, INC. [Life Technologies]	GeneChip System 3000Dx v.2	2007-11-28

Similar & Related FDA Registered Companies

• LIFE TECHNOLOGIES CORPORATION
• Life Sciences Advanced Technologies, Inc.
• Life Wear Technologies, Inc.
• Lifecycle Biotechnologies, LP
• Lifeloc Technologies Inc
• LIFEWATCH TECHNOLOGIES LTD.
• LIFE TECHNOLOGIES, INC.
• LIFESTREAM TECHNOLOGIES, INC.
• LIFEQUEST ENDOSCOPIC TECHNOLOGIES, INC.
• LIFE MEDICAL TECHNOLOGIES, INC.
• LIFE ENHANCEMENT TECHNOLOGIES, LLC.
• LIFEMED TECHNOLOGIES, INC.
• LIFE TECHNOLOGIES CORPORATION5781 Van Allen Waycarlsbad, CA 92008 PMA NumberP160045 Supplement NumberS038 Date Received08/05/2022 Decision Date02/01/2023 Product Code PQP  Advisory Committee Pathology Clinical TrialsNCT02609776 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No
• LIFE TECHNOLOGIES CORPORATION5781 Van Allen Waycarlsbad, CA 92008 PMA NumberP160045 Supplement NumberS037 Date Received06/14/2022 Decision Date09/19/2022 Product Code PQP  Advisory Committee Pathology Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• LIFE TECHNOLOGIES CORPORATION5781 Van Allen Waycarlsbad, CA 92008 PMA NumberP160045 Supplement NumberS036 Date Received03/29/2022 Decision Date08/11/2022 Product Code PQP  Advisory Committee Pathology Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• LIFE TECHNOLOGIES CORPORATION5781 Van Allen Waycarlsbad, CA 92008 PMA NumberP160045 Supplement NumberS035 Date Received03/08/2022 Decision Date08/11/2022 Product Code PQP  Advisory Committee Pathology Clinical TrialsNCT03505710 Supplement Typepanel Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• LIFE WEAR TECHNOLOGIES
• LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
• LIFE TECHNOLOGIES LIMITED

Related Finance Registrations

NCAGE Code	39AL2	LIFE TECHNOLOGIES!DBA PERSONAL TECHNOLOGIES
CAGE Code	39AL2	LIFE TECHNOLOGIES PERSONAL TECHNOLOGIES
DUNS	196919190	Life Technologies

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092910867	Shanghai ,China (Mainland) -> Baltimore, Maryland	MEDICAL TEST PLASTIC TRAY (USED IN LABORATORY )	501 CTN
202009298030	Hong Kong,Hong Kong -> Norfolk, Virginia	COMPUTER EQUIPMENT	3329 CTN
202009298030	Hong Kong,Hong Kong -> Norfolk, Virginia	COMPUTER EQUIPMENT	3329 CTN
202009298030	Hong Kong,Hong Kong -> Norfolk, Virginia	COMPUTER EQUIPMENT	3329 CTN
2020092511480	Shanghai ,China (Mainland) -> Baltimore, Maryland	MEDICAL TEST PLASTIC TRAY (USED IN LABORATORY )	501 CTN
2020092415278	Shanghai ,China (Mainland) -> Baltimore, Maryland	MEDICAL TEST PLASTIC TRAY (USED IN LABORATORY )	501 CTN
2020092112737	Shanghai ,China (Mainland) -> Baltimore, Maryland	MEDICAL TEST PLASTIC TRAY (USED INLABORATORY)	570 CTN
202009195673	Hong Kong,Hong Kong -> Norfolk, Virginia	COMPUTER EQUIPMENT	1050 CTN
202009148663	Hong Kong,Hong Kong -> Norfolk, Virginia	COMPUTER EQUIPMENT	1050 CTN
2020090910293	Shanghai ,China (Mainland) -> Baltimore, Maryland	PLASTIC PLATE ,CAP ETC.	232 CTN