FDA.reportPublic FDA data

MiSeqDx Universal Kit 1.0

Primary DI
00816270020040
Brand
MiSeqDx Universal Kit 1.0
Company
ILLUMINA, INC.
Model
15038741
Catalog number
DX-103-1001
Device description
The MiSeqDx Universal Kit 1.0 is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in the subsequent targeted re-sequencing of the resulting sample libraries. User-supplied analyte specific reagents are required for the preparation of libraries targeting specific genomic regions of interest. MiSeqDx Universal Kit 1.0 (2 Run) is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier: 15039490 MiSeqDx Universal Kit 1.0 1/515039485 MiSeqDx Universal Kit 1.0 1A15039488 MiSeqDx Universal Kit 1.0 1B15039492 MiSeqDx Universal Kit 1.0 2/515039498 MiSeqDx Universal Kit 1.0 3/515039494 MiSeqDx Universal Kit 1.0 3A15039496 MiSeqDx Universal Kit 1.0 3B15039500 MiSeqDx Universal Kit 1.0 4/515039503 MiSeqDx Universal Kit 1.0 5/5
Published
2016-09-21
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN130042000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN130042000MISEQDX UNIVERSAL KIT 1.0Illumina, Inc.2013-11-19PFT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816270020040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816270020040008162700200408162700200400816270020040

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
033305264
Device count
1
Kit
true
Lot or batch
true
Expiration 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
00816270020330DRAGEN™ for Illumina DNA Prep with Enrichment Dx Application for NextSeq 550DxILLUMINA, INC.PFT2026-04-27
04250306300212InviTrap Spin Universal RNA Kit (50)Invitek Molecular GmbHPFT2025-01-20
04250306300229InviTrap Spin Universal RNA Kit (250)Invitek Molecular GmbHPFT2025-01-20
04250306300410PSP Spin Stool DNA Basic Kit (50)Invitek Molecular GmbHPFT2025-01-20
04250306300427PSP Spin Stool DNA Basic Kit (250)Invitek Molecular GmbHPFT2025-01-20
04250306300922PSP SalivaGene DNA Kit (250)Invitek Molecular GmbHPFT2025-01-20
10190302018241MagMAX™ Viral/Pathogen II Nucleic Acid Isolation KitTHERMO FISHER SCIENTIFIC BALTICS UABPFT2023-03-22
00816270020392Local Run Manager DNA GenerateFASTQ Dx Module for MiSeq™DxILLUMINA, INC.PFT2022-11-07
00816270020415Local Run Manager DNA GenerateFASTQ Dx Module for NextSeq™ 550DxILLUMINA, INC.PFT2022-11-07
00816270020743DRAGEN™ for Illumina® DNA Prep with Enrichment Dx for NovaSeq™ 6000DxILLUMINA, INC.PFT2022-11-07
10190302015769MagMAX™ MVP II BINDING BEADSTHERMO FISHER SCIENTIFIC BALTICS UABPFT2022-10-26
10190302015776MagMAX™ Viral/Pathogen Binding SolutionTHERMO FISHER SCIENTIFIC BALTICS UABPFT2022-10-26
10190302015783MagMAX™ Viral/Pathogen Wash SolutionTHERMO FISHER SCIENTIFIC BALTICS UABPFT2022-10-26
10190302015790MagMAX™ Viral/Pathogen Proteinase KTHERMO FISHER SCIENTIFIC BALTICS UABPFT2022-10-26
10190302015806MagMAX™ Viral/Pathogen Elution BufferTHERMO FISHER SCIENTIFIC BALTICS UABPFT2022-10-26
00816270020453Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set A (96 samples)ILLUMINA, INC.PFT2022-10-20
00816270020460Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set B (96 samples)ILLUMINA, INC.PFT2022-10-20
00816270020477Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set A (16 samples)ILLUMINA, INC.PFT2022-10-20
00816270020484Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set B (16 samples)ILLUMINA, INC.PFT2022-10-20
00816270020538NovaSeq™ 6000Dx S2 Reagent v1.5 Kit (300 cycles)ILLUMINA, INC.PFT2022-10-18
00816270020545NovaSeq™ 6000Dx S2 Buffer CartridgeILLUMINA, INC.PFT2022-10-18
00816270020552NovaSeq™ 6000Dx Library TubeILLUMINA, INC.PFT2022-10-18
00816270020576NovaSeq™ 6000Dx S4 Buffer CartridgeILLUMINA, INC.PFT2022-10-18
00816270020583NovaSeq™ 6000Dx Library Tube, 24 packILLUMINA, INC.PFT2022-10-18
00816270020668MiSeq™Dx Reagent Kit v3 MicroILLUMINA, INC.PFT2022-05-20
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