FDA.reportPublic FDA data

MiSeqDx Instrument

Primary DI
00816270020002
Brand
MiSeqDx Instrument
Company
ILLUMINA, INC.
Model
15036706
Catalog number
DX-410-1001
Device description
The Illumina MiSeqDx is a sequencing instrument that measures fluorescence signals of labeled nucleotides through theuse of instrument specific reagents and flow cells (MiSeqDx Universal Kit 1.0), imaging hardware, and data analysissoftware.
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PFFHigh Throughput Dna Sequence Analyzer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PFFHigh Throughput Dna Sequence AnalyzerImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN130011000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN130011000ILLUMINA MISEQDX PLATFORMIllumina, Inc.2013-11-19PFF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816270020002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816270020002008162700200028162700200020816270020002

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid sequence analyser IVD, next-generation sequencing (NGS)A mains electricity (AC-powered) automated laboratory instrument intended to determine the sequence of nucleotides in a nucleic acid library [pre-constructed from deoxyribonucleic acid (DNA) or ribonucleic acid (RNA)] for genetic analysis of a clinical specimen, using a next-generation sequencing (NGS) technique. It consists of a detector (e.g., fluorescent, luminescent or electrochemical) which detects signals from incorporated nucleotides, as well as sample processing, data processing, and/or data display software. It operates with minimal technician input and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
033305264
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816270020415Local Run Manager DNA GenerateFASTQ Dx Module for NextSeq™ 550Dx20063024200630242022-11-07
00816270020330DRAGEN™ for Illumina DNA Prep with Enrichment Dx Application for NextSeq 550Dx200747302026-04-27
00816270020217TruSight™ Oncology Comprehensive 200325732024-12-09
00816270020644TruSight™ Oncology RNA Control200650422024-12-09
00816270020651TruSight™ Oncology DNA Control IVD200650412024-12-09
00816270020088Praxis Extended RAS Panel20012431200124312017-08-28
00816270020262Local Run Manager CF Clinical Sequencing Analysis Module20046734200467342023-06-15
00816270020286Local Run Manager CF 139 Variant Analysis Module20047009200470092023-06-15
00816270020378Local Run Manager CF 139-Variant 2.0 Micro Analysis Module20072975200729752023-06-15
00816270020385Local Run Manager CF Clinical Seq 2.0 Micro Analysis Module20072974200729742023-06-15
00816270020149TruSight™ Cystic Fibrosis Library Preparation20036925200369252020-04-09
00816270020019MiSeqDx CF 139 Variant Assay (2 Run)15036580DX-102-10042016-09-21
00816270020026MiSeqDx Cystic Fibrosis Clinical Sequencing Assay (6 Run)15036620DX-102-10012016-09-21
00816270020033MiSeqDx Cystic Fibrosis 139 Variant Assay (20 Run)15036577DX-102-10032017-08-14
00816270020392Local Run Manager DNA GenerateFASTQ Dx Module for MiSeq™Dx20063022200630222022-11-07
00816270020743DRAGEN™ for Illumina® DNA Prep with Enrichment Dx for NovaSeq™ 6000Dx20074609200746092022-11-07
00816270020453Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set A (96 samples)20051352200513522022-10-20
00816270020460Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set B (96 samples)20051353200513532022-10-20
00816270020477Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set A (16 samples)20051354200513542022-10-20
00816270020484Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set B (16 samples)20051355200513552022-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10190302017794Ion Torrent™ Genexus™ Dx Integrated SequencerLIFE TECHNOLOGIES HOLDINGS PTE. LTD.PFF2025-10-13
10190302018883Ion Torrent Genexus Dx SoftwareLIFE TECHNOLOGIES HOLDINGS PTE. LTD.PFF2025-07-24
10190302019958Torrent Suite DX SW, Installer V5.14.2LIFE TECHNOLOGIES HOLDINGS PTE. LTD.PFF2025-02-19
10190302017848Torrent Suite DX SW, Installer V5.14LIFE TECHNOLOGIES HOLDINGS PTE. LTD.PFF2023-03-20
00816270020637NovaSeq™ 6000DxILLUMINA, INC.PFF2022-10-18
00816270020699MiSeq™ Dx (China)ILLUMINA, INC.PFF2022-04-25
10190302016810Torrent Suite DX, Installer v5.12.5LIFE TECHNOLOGIES HOLDINGS PTE. LTD.PFF2022-01-04
10190302014090Torrent Suite DX, Installer v5.8LIFE TECHNOLOGIES HOLDINGS PTE. LTD.PFF2019-03-27
00816270020125NextSeq 550Dx Sequencing SystemILLUMINA, INC.PFF2018-02-09
10190302005654Torrent Suite™ Dx SW, V5.6.4LIFE TECHNOLOGIES HOLDINGS PTE. LTD.PFF2017-08-15
08885013950069Sentosa ST401iVELA OPERATIONS SINGAPORE PTE. LTD.PFF2017-03-28
08885013950076Sentosa ST401eVELA OPERATIONS SINGAPORE PTE. LTD.PFF2016-10-19
08885013950045Sentosa SQ301 SequencerVELA OPERATIONS SINGAPORE PTE. LTD.PFF2016-09-22
10190302000833Personal Genome Machine™ Dx (PGM™) DxLIFE TECHNOLOGIES HOLDINGS PTE. LTD.PFF2016-08-01
10190302000840Ion PGM™ Dx Chip MinifugeLIFE TECHNOLOGIES HOLDINGS PTE. LTD.PFF2016-08-01
10190302000857Ion One Touch™ DxLIFE TECHNOLOGIES HOLDINGS PTE. LTD.PFF2016-08-01
10190302000864Ion One Touch™ ES DxLIFE TECHNOLOGIES HOLDINGS PTE. LTD.PFF2016-08-01