Illumina Inc

FDA Filings

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

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ILMN

DUNS 033305264

FDA Filings

Device Company	Device	Date
GUDID 00816270020385 ILLUMINA, INC.	Local Run Manager CF Clinical Seq 2.0 Micro Analysis Module 20072974	2023-07-13
GUDID 00816270020378 ILLUMINA, INC.	Local Run Manager CF 139-Variant 2.0 Micro Analysis Module 20072975	2023-07-13
GUDID 00816270020286 ILLUMINA, INC.	Local Run Manager CF 139 Variant Analysis Module 20047009	2023-07-13
GUDID 00816270020262 ILLUMINA, INC.	Local Run Manager CF Clinical Sequencing Analysis Module 20046734	2023-07-13
GUDID 00816270020743 ILLUMINA, INC.	DRAGEN™ for Illumina® DNA Prep with Enrichment Dx for NovaSeq™ 6000Dx 20074609	2022-11-15
GUDID 00816270020415 ILLUMINA, INC.	Local Run Manager DNA GenerateFASTQ Dx Module for NextSeq™ 550Dx 20063024	2022-11-15
GUDID 00816270020392 ILLUMINA, INC.	Local Run Manager DNA GenerateFASTQ Dx Module for MiSeq™Dx 20063022	2022-11-15
GUDID 00816270020484 ILLUMINA, INC.	Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set B (16 samples) 20051355	2022-10-28
GUDID 00816270020477 ILLUMINA, INC.	Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set A (16 samples) 20051354	2022-10-28
GUDID 00816270020460 ILLUMINA, INC.	Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set B (96 samples) 20051353	2022-10-28
GUDID 00816270020453 ILLUMINA, INC.	Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set A (96 samples) 20051352	2022-10-28
GUDID 00816270020637 ILLUMINA, INC.	NovaSeq™ 6000Dx 20068232	2022-10-26
GUDID 00816270020583 ILLUMINA, INC.	NovaSeq™ 6000Dx Library Tube, 24 pack 20062291	2022-10-26
GUDID 00816270020576 ILLUMINA, INC.	NovaSeq™ 6000Dx S4 Buffer Cartridge 20062293	2022-10-26
GUDID 00816270020569 ILLUMINA, INC.	NovaSeq™ 6000Dx S4 Reagent v1.5 Kit (300 cycles) 20046933	2022-10-26
GUDID 00816270020552 ILLUMINA, INC.	NovaSeq™ 6000Dx Library Tube 20062290	2022-10-26
GUDID 00816270020545 ILLUMINA, INC.	NovaSeq™ 6000Dx S2 Buffer Cartridge 20062292	2022-10-26
GUDID 00816270020538 ILLUMINA, INC.	NovaSeq™ 6000Dx S2 Reagent v1.5 Kit (300 cycles) 20046931	2022-10-26
GUDID 00816270020668 ILLUMINA, INC.	MiSeq™Dx Reagent Kit v3 Micro 20063860	2022-05-30
GUDID 00816270020699 ILLUMINA, INC.	MiSeq™ Dx (China) 20014053	2022-05-03
PMA P160038S020 Illumina, Inc.	Praxis Extended RAS Panel	2021-05-21
PMA P160038S018 Illumina, Inc.	Praxis Extended RAS Panel	2020-12-04
PMA P160038S017 Illumina, Inc.	Praxis Extended RAS Panel	2020-09-02
GUDID 00816270020156 ILLUMINA, INC.	MiSeq™ Dx Reagent Kit v3 20037124	2020-08-11
PMA P160038S016 Illumina, Inc.	Praxis Extended RAS Panel	2020-04-28
GUDID 00816270020149 ILLUMINA, INC.	TruSight™ Cystic Fibrosis Library Preparation 20036925	2020-04-17
PMA P160038S015 Illumina, Inc.	Praxis Extended RAS Panel	2020-01-24
PMA P160038S014 Illumina, Inc.	Praxis Extended RAS Panel	2019-11-04
PMA P160038S013 Illumina, Inc.	Praxis Extended RAS Panel	2019-08-08
GUDID 00816270020071 ILLUMINA, INC.	MiSeqDx Reagent Kit v3 20012552	2019-07-10
PMA P160038S012 Illumina, Inc.	Praxis Extended RAS Panel	2019-05-16
GUDID 00816270020132 ILLUMINA, INC.	NextSeq™ 550Dx High Output Reagent Kit v2.5 (75 cycles) 20028870	2019-04-23
PMA P160038S010 Illumina, Inc.	Praxis Extended RAS Panel	2019-03-25
GUDID 00816270020118 ILLUMINA, INC.	NextSeq™ 550Dx High Output Reagent Kit v2.5 (300 cycles) 20028871	2019-03-11
PMA P160038S009 Illumina, Inc.	Praxis Extended RAS Panel	2019-03-05
GUDID 00816270020095 ILLUMINA, INC.	NextSeq550Dx Reagent Kit v2(300 cyc) IVD 20019554	2019-03-01
PMA P160038S008 Illumina, Inc.	Praxis Extended RAS Panel	2019-02-25
PMA P160038S007 Illumina, Inc.	Praxis (MiSeqDx) Extended RAS Panel	2019-01-08
PMA P160038S006 Illumina, Inc.	Praxis Extended RAS Panel	2018-09-20
PMA P160038S005 Illumina, Inc.	MiSeqDx Extended RAS Panel	2018-09-04
GUDID 00816270020088 ILLUMINA, INC.	Praxis Extended RAS Panel 20012431	2018-07-06
GUDID 00816270020040 ILLUMINA, INC.	MiSeqDx Universal Kit 1.0 DX-103-1001	2018-07-06
GUDID 00816270020033 ILLUMINA, INC.	MiSeqDx Cystic Fibrosis 139 Variant Assay (20 Run) DX-102-1003	2018-07-06
GUDID 00816270020026 ILLUMINA, INC.	MiSeqDx Cystic Fibrosis Clinical Sequencing Assay (6 Run) DX-102-1001	2018-07-06
GUDID 00816270020002 ILLUMINA, INC.	MiSeqDx Instrument DX-410-1001	2018-07-06
PMA P160038S004 Illumina, Inc.	Praxis Extended RAS Panel	2018-06-25
PMA P160038S003 Illumina, Inc.	MiSeqDx Praxis Extended RAS Panel	2018-05-01
PMA P160038S001 Illumina, Inc.	Praxis Extended RAS Panel	2018-04-11
GUDID 00816270020125 ILLUMINA, INC.	NextSeq 550Dx Sequencing System 20005715	2018-03-29
GUDID 00816270020064 ILLUMINA, INC.	TruSeq Custom Amplicon Kit Dx - FFPE QC 20006259	2018-03-29
GUDID 00816270020057 ILLUMINA, INC.	TruSeq Custom Amplicon Kit Dx 20005718	2018-03-29
GUDID 00816270020019 ILLUMINA, INC.	MiSeqDx CF 139 Variant Assay (2 Run) DX-102-1004	2018-03-29
PMA P160038S002 Illumina, Inc.	Praxis Extended RAS Panel	2018-03-26
PMA P160038 Illumina, Inc.	Praxis Extended RAS Panel	2017-06-29
PMN K132750 ILLUMINA, INC.	ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY	2013-11-19
PMN K124006 ILLUMINA, INC.	ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY	2013-11-19
De Novo DEN130042 ILLUMINA, INC.	MISEQDX UNIVERSAL KIT 1.0	2013-11-19
De Novo DEN130011 ILLUMINA, INC.	ILLUMINA MISEQDX PLATFORM	2013-11-19
PMN K093129 ILLUMINA, INC.	ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II	2010-04-28
PMN K093128 ILLUMINA, INC.	ILLUMINA BEADXPRESS SYSTEM	2010-04-28

Similar & Related FDA Registered Companies

• 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

Related Finance Registrations

NCAGE Code	1WCS2	ILLUMINA, INC.
CAGE Code	1WCS2	ILLUMINA, INC.
S.A.M. Registration	1WCS2 [33305264]	ILLUMINA, INC.
SEC	0001110803	ILLUMINA, INC. of DELAWARE

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020082118827	Stadersand,Federal Republic of Germany -> Los Angeles, California	DISCOVERY MAGNETRON SPUTTERING SYSTEM INVOICE NO. 100034688 HS CODE: 84862000	1 PKG
2020082029562	Stadersand,Federal Republic of Germany -> Los Angeles, California	DISCOVERY MAGNETRON SPUTTERING SYSTEM INVOICE NO. 100034688 HS CODE: 84862000	1 PKG
2020070812633	Southhampton,United Kingdom -> Los Angeles, California	PACKAGING	21 BOX
2020070712634	Southhampton,United Kingdom -> Los Angeles, California	PACKAGING	21 BOX
2020052743095	Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey	LASER EQUIPMENT	14 CTN
2020051236888	Liverpool,United Kingdom -> New York/Newark Area, Newark, New Jersey	LASER EQUIPMENT	12 CTN