Affymetrix Inc

FDA Filings

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

FDA Registration(s)

• 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 Filings

Device Company	Device	Date
GUDID 00856826006104 AFFYMETRIX, INC.	CytoScan Dx WS A 902090	2020-02-10
GUDID 00856826006166 AFFYMETRIX, INC.	Affymetrix 902111	2018-03-29
GUDID 00856826006159 AFFYMETRIX, INC.	Affymetrix 902108	2018-03-29
GUDID 00856826006142 AFFYMETRIX, INC.	Affymetrix 902107	2018-03-29
GUDID 00856826006135 AFFYMETRIX, INC.	Affymterix 902110	2018-03-29
GUDID 00856826006128 AFFYMETRIX, INC.	Affymetrix 902109	2018-03-29
GUDID 00856826006111 AFFYMETRIX, INC.	Affymetrix 902091	2018-03-29
GUDID 00856826006098 AFFYMETRIX, INC.	Affymetrix 902150	2018-03-29
GUDID 00856826006081 AFFYMETRIX, INC.	Affymetrix 520969	2018-03-29
GUDID 00856826006074 AFFYMETRIX, INC.	Affymetrix 610525	2018-03-29
GUDID 00856826006067 AFFYMETRIX, INC.	Affymetrix 610466	2018-03-29
GUDID 00856826006050 AFFYMETRIX, INC.	Affymetrix 610533	2018-03-29
GUDID 00856826006043 AFFYMETRIX, INC.	Affymetrix 00-0146	2018-03-29
GUDID 00856826006036 AFFYMETRIX, INC.	Affymetrix 00-0336	2018-03-29
GUDID 00856826006029 AFFYMETRIX, INC.	Affymetrix 00-0335	2018-03-29
GUDID 00085626006104 AFFYMETRIX, INC.	Affymetrix 902090	2018-03-29
NSU AFFYMETRIX, INC. [Life Technologies]	Concerto Imager	2017-12-20
PMN DEN130018 | PFX AFFYMETRIX, INC. [Life Technologies]	CytoScan? Dx Assay	2014-05-26
De Novo DEN130018 Affymetrix, Inc.	CYTOSCAN(R) DX	2014-01-17
PMN K103112 Affymetrix, Inc.	AFFYMETRIX GENE PROFILING REAGENTS	2011-05-04
PMN K080995 Affymetrix, Inc.	MODIFICATION TO AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM	2008-07-30
PMN DEN040012 | NSU AFFYMETRIX, INC. [Life Technologies]	GeneChip System 3000Dx v.2	2007-11-28
De Novo DEN040012 Affymetrix, Inc.	AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM	2004-12-23

Related Finance Registrations

NCAGE Code	086A8	AFFYMETRIX INC
NCAGE Code	1KQL1	AFFYMETRIX, INC.
CAGE Code	086A8	AFFYMETRIX INC
CAGE Code	1KQL1	AFFYMETRIX, INC.
DUNS	804682573	Affymetrix, Inc.
SEC	0000913077	AFFYMETRIX INC of DELAWARE

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020080637521	Singapore,Singapore -> Los Angeles, California	USED KLA MACHINE FOR ENGINEERING STUDY IN USA	1 PKG