Illumina

FDA Filings

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

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

• Karen Gutekunst

FDA Registration(s)

• Registration Number: 3006296346
• FEI Number: 3005095756
• Name: Illumina Hayward
• Owner & Operator: Illumina
• Contact Address: 5200 Illumina Way ; San Diego CA 92122 US
• Official Correspondent:
  • Karen Gutekunst
  • x-858-2555541-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 25861 Industrial Blvd ; Hayward, CA 94545 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 3007102730
• FEI Number: 3007102730
• Name: Karen Gutekunst
• Owner & Operator: Illumina
• Contact Address: 5200 Illumina Way ; San Diego CA 92122 US
• Official Correspondent:
  • Karen Gutekunst
  • x-858-2555541-x
• US Agent:
  • Karen Gutekunst
  • ILLUMINA
  • 858 2555541
  • kgutekunst@illumina.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 5200 Illumina Way ; San Diego, CA 92122 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 3003218906
• FEI Number: 3003218906
• Name: ILLUMINA
• Owner & Operator: Illumina
• Contact Address: 5200 Illumina Way ; San Diego CA 92122 US
• Official Correspondent:
  • Karen Gutekunst
  • x-858-2555541-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 5200 Illumina Way ; San Diego, CA 92122 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PFF Karen Gutekunst [Illumina]	NextSeq? 550Dx Instrument	2017-12-04
PFF ILLUMINA	NextSeq? 550Dx Instrument	2017-12-04
PFT Karen Gutekunst [Illumina]	TruSeq? Custom Amplicon Kit Dx	2017-09-01
PFT Karen Gutekunst [Illumina]	TruSeq? Custom Amplicon Kit Dx- FFPE	2017-09-01
PFT Karen Gutekunst [Illumina]	NextSeq? 550Dx High Output Reagent Kit v2.5 (75 cycles)	2017-09-01
PFT Karen Gutekunst [Illumina]	NextSeq? 550Dx High Output Reagent Kit v2.5 (300 cycles)	2017-09-01
PFT Karen Gutekunst [Illumina]	NextSeq? 550Dx High Output Reagent Kit v2 (300 cycles)	2017-09-01
PFT Karen Gutekunst [Illumina]	MiSeq?Dx Reagent Kit V3	2017-09-01
PFT ILLUMINA	TruSeq? Custom Amplicon Kit Dx	2017-09-01
PFT ILLUMINA	TruSeq? Custom Amplicon Kit Dx- FFPE	2017-09-01
PFT ILLUMINA	NextSeq? 550Dx High Output Reagent Kit v2.5 (75 cycles)	2017-09-01
PFT ILLUMINA	NextSeq? 550Dx High Output Reagent Kit v2.5 (300 cycles)	2017-09-01
PFT ILLUMINA	NextSeq? 550Dx High Output Reagent Kit v2 (300 cycles)	2017-09-01
PFT ILLUMINA	MiSeq?Dx Reagent Kit V3	2017-09-01
PMN P160038 | PQP ILLUMINA	Praxis Extended RAS Panel	2017-08-21
PMN DEN130042 | PFT ILLUMINA	MiSeqDx Universal Kit 1.0	2014-02-25
PMN K132750 | PFS ILLUMINA	TruSight Cystic Fibrosis Library Prep	2014-01-10
PMN K132750 | PFS ILLUMINA	MiSeqDx Cystic Fibrosis Clinical Sequencing Assay	2014-01-10
PMN K124006 | PFR ILLUMINA	MiSeqDx Cystic Fibrosis 139-Variant Assay	2014-01-10
PMN DEN130011 | PFF Illumina Hayward [Illumina]	MiSeq?Dx instrument	2014-01-10
PMN DEN130011 | PFF ILLUMINA	MiSeq?Dx instrument	2014-01-10

Similar & Related FDA Registered Companies

• ILLUMINA, INC.
• Illumina, Inc.5200 Illumina Waysan Diego, CA 92122 PMA NumberP160038 Supplement NumberS024 Date Received12/22/2022 Decision Date01/13/2023 Product Code PQP  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Illumina, Inc.5200 Illumina Waysan Diego, CA 92122 PMA NumberP160038 Supplement NumberS023 Date Received08/18/2022 Decision Date08/30/2022 Product Code PQP  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Illumina, Inc.5200 Illumina Waysan Diego, CA 92122 PMA NumberP160038 Supplement NumberS022 Date Received06/13/2022 Decision Date07/05/2022 Product Code PQP  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Illumina, Inc.5200 Illumina Waysan Diego, CA 92122 PMA NumberP160038 Supplement NumberS021 Date Received02/28/2022 Decision Date03/28/2022 Product Code PQP  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2018120331828	Singapore,Singapore -> Los Angeles, California	PLASTIC PARTS (ON 8 PALLETS)	288 CTN
2018120331828	Singapore,Singapore -> Los Angeles, California	PLACTIC PARTS (ON 16 PALLETS)	288 CTN
2018110824174	Singapore,Singapore -> Los Angeles, California	PLACTIC PARTS	288 CTN
2018110824174	Singapore,Singapore -> Los Angeles, California	PLASTIC PARTS	288 CTN
2018072318352	Singapore,Singapore -> Los Angeles, California	PLACTIC PARTS	72 CTN
2018040317880	Singapore,Singapore -> Los Angeles, California	PLASTIC PARTS (ON 16 PALLETS)	192 CTN
2018032319980	Singapore,Singapore -> Los Angeles, California	PLACTIC PARTS (ON 5 PALLETS)	240 CTN
2018032319980	Singapore,Singapore -> Los Angeles, California	PLASTIC PARTS (ON 15 PALLETS)	240 CTN
20180220106	Singapore,Singapore -> Los Angeles, California	PLASTIC PARTS (ON 16 PALLETS)	192 CTN
2018020715731	Singapore,Singapore -> Los Angeles, California	PLASTIC PARTS (ON 5 PALLETS)	240 CTN
2018020715731	Singapore,Singapore -> Los Angeles, California	PLACTIC PARTS (ON 10 PALLETS)	240 CTN
201801267730	Singapore,Singapore -> Los Angeles, California	PLASTIC PARTS (ON 6 PALLETS)	252 CTN
201801267730	Singapore,Singapore -> Los Angeles, California	PLACTIC PARTS (ON 15 PALLETS)	252 CTN