Illumina, Inc

FDA Filings

This page includes the latest FDA filings for Illumina, Inc. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
ILLUMINA, INC.
ILLUMINA MISEQDX CYSTIC FIBROSIS 139-VARIANT ASSAY2013-11-19
ILLUMINA, INC.
ILLUMINA MISEQDX CYSTIC FIBROSIS CLINICAL SEQUENCING ASSAY2013-11-19

Latest Premarket Applications

PMAManufacturerDevice NameDate
Illumina, Inc.
Praxis Extended RAS Panel2019-11-04
Illumina, Inc.
Praxis Extended RAS Panel2019-08-08
Illumina, Inc.
Praxis Extended RAS Panel2019-05-16
Illumina, Inc.
Praxis Extended RAS Panel2019-03-25
Illumina, Inc.
Praxis Extended RAS Panel2019-03-05
Illumina, Inc.
Praxis Extended RAS Panel2019-02-25
Illumina, Inc.
Praxis (MiSeqDx) Extended RAS Panel2019-01-08
Illumina, Inc.
Praxis Extended RAS Panel2018-09-20
Illumina, Inc.
MiSeqDx Extended RAS Panel2018-09-04
Illumina, Inc.
Praxis Extended RAS Panel2018-06-25
Illumina, Inc.
MiSeqDx Praxis Extended RAS Panel2018-05-01
Illumina, Inc.
Praxis Extended RAS Panel2018-04-11
Illumina, Inc.
Praxis Extended RAS Panel2018-03-26
Illumina, Inc.
Praxis Extended RAS Panel2017-06-29

Latest De Novo Filings

De NovoManufacturerDevice NameDate
ILLUMINA, INC.
ILLUMINA MISEQDX PLATFORM2013-11-19
ILLUMINA, INC.
MISEQDX UNIVERSAL KIT 1.02013-11-19

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
MiSeqDx Reagent Kit v3
ILLUMINA, INC.2019-07-10
NextSeq™ 550Dx High Output Reagent Kit v2.5 (75 cycles)
ILLUMINA, INC.2019-04-23
NextSeq550Dx Reagent Kit v2(300 cyc) IVD
ILLUMINA, INC.2019-03-01
Praxis Extended RAS Panel
ILLUMINA, INC.2018-07-06
MiSeqDx Universal Kit 1.0
ILLUMINA, INC.2018-07-06
MiSeqDx Cystic Fibrosis 139 Variant Assay (20 Run)
ILLUMINA, INC.2018-07-06
MiSeqDx Cystic Fibrosis Clinical Sequencing Assay
ILLUMINA, INC.2018-07-06
MiSeqDx Instrument
ILLUMINA, INC.2018-07-06
NextSeq 550Dx Sequencing System
ILLUMINA, INC.2018-03-29
TruSeq Custom Amplicon Kit Dx - FFPE QC
ILLUMINA, INC.2018-03-29
TruSeq Custom Amplicon Kit Dx
ILLUMINA, INC.2018-03-29
MiSeqDx CF 139 Variant Assay (2 Run)
ILLUMINA, INC.2018-03-29

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