FDA.reportPublic FDA data

DRAGEN™ for Illumina DNA Prep with Enrichment Dx Application for NextSeq 550Dx

Primary DI
00816270020330
Brand
DRAGEN™ for Illumina DNA Prep with Enrichment Dx Application for NextSeq 550Dx
Company
ILLUMINA, INC.
Model
20074730
Device description
The DRAGEN™ for Illumina® DNA Prep with Enrichment Dx application for NextSeq 550Dx is used for sequencing run setup, run monitoring, primary and secondary analysis on the NextSeq 550Dx instrument for the Illumina® DNA Prep with Enrichment Dx library preparation assay. The software (SW) includes the UDI information in the User Interface.
Published
2026-04-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
PFTReagents For Molecular Diagnostic Test Systems

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PFTReagents For Molecular Diagnostic Test SystemsClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816270020330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816270020330008162700203308162700203300816270020330

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid sequencing reagent kit IVDA collection of reagents and other associated materials intended to be used on-board a nucleic acid sequencing instrument for the genetic analysis of a clinical specimen. It typically consists of buffers, primers, enzymes (e.g., DNA polymerase, DNA ligase) and deoxynucleotides (dNTPs). It does not contain analyte-specific reagents and is not intended to be used for whole genome or complementary deoxyribonucleic acid (cDNA) library construction.

Regulatory Flags#

DUNS number
033305264
Device count
1
Premarket exempt
true
Lot or batch
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
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
00816270020538NovaSeq™ 6000Dx S2 Reagent v1.5 Kit (300 cycles)20046931200469312022-10-18

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10190302015806MagMAX™ Viral/Pathogen Elution BufferTHERMO FISHER SCIENTIFIC BALTICS UABPFT2022-10-26
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00816270020538NovaSeq™ 6000Dx S2 Reagent v1.5 Kit (300 cycles)ILLUMINA, INC.PFT2022-10-18
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