Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set B (96 samples) 20051353

GUDID 00816270020460

The Illumina® DNA Prep with Enrichment Dx Kit is a set of reagents and consumables used to prepare sample libraries from peripheral whole blood and formalin-fixed, paraffin-embedded tissue. User-supplied probe panels are required for the preparation of libraries targeting specific genomic regions of interest. The generated sample libraries are intended for use on Illumina's sequencing systems. The Illumina® DNA Prep with Enrichment Dx Kit is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier. 20050025, Illumina® Prep Dx Tagmentation Reagents 1; 20050026, Illumina® DNA Prep Dx Tagmentation Reagents 2; 20050027, Illumina® Prep Dx Tagmentation Reagents 3; 20050028, Illumina® DNA Prep Dx Enrichment Reagents 1; 20050029, Illumina® DNA Prep Dx Enrichment Reagents 2; 20050030, Illumina® Prep Dx Cleanup Beads; and 20050039, Illumina® Unique Dual Index Dx Set B (96 Indexes).

ILLUMINA, INC.

Nucleic acid sequencing reagent kit IVD
Primary Device ID00816270020460
NIH Device Record Keydda51228-da33-453d-8544-c8c1b4edc1c0
Commercial Distribution StatusIn Commercial Distribution
Brand NameIllumina® DNA Prep with Enrichment Dx with UDP Indexes Set B (96 samples)
Version Model Number20051353
Catalog Number20051353
Company DUNS033305264
Company NameILLUMINA, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-809-4566
Emailtechsupport@illumina.com
Phone800-809-4566
Emailtechsupport@illumina.com
Phone800-809-4566
Emailtechsupport@illumina.com
Phone800-809-4566
Emailtechsupport@illumina.com
Phone800-809-4566
Emailtechsupport@illumina.com
Phone800-809-4566
Emailtechsupport@illumina.com
Phone800-809-4566
Emailtechsupport@illumina.com
Phone800-809-4566
Emailtechsupport@illumina.com
Phone800-809-4566
Emailtechsupport@illumina.com
Phone800-809-4566
Emailtechsupport@illumina.com
Phone800-809-4566
Emailtechsupport@illumina.com
Phone800-809-4566
Emailtechsupport@illumina.com
Phone800-809-4566
Emailtechsupport@illumina.com
Phone800-809-4566
Emailtechsupport@illumina.com
Phone800-809-4566
Emailtechsupport@illumina.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween -25 Degrees Celsius and -15 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816270020460 [Primary]

FDA Product Code

PFTReagents For Molecular Diagnostic Test Systems

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-28
Device Publish Date2022-10-20

Devices Manufactured by ILLUMINA, INC.

00816270020262 - Local Run Manager CF Clinical Sequencing Analysis Module2023-07-13 The Local Run Manager CF Clinical Sequencing analysis module is for use with Illumina MiSeqDx Cystic Fibrosis Clinical Sequencin
00816270020286 - Local Run Manager CF 139 Variant Analysis Module2023-07-13 The Local Run Manager CF 139 Variant analysis module is for use with Illumina MiSeqDx Cystic Fibrosis 139-Variant Assay. The ass
00816270020378 - Local Run Manager CF 139-Variant 2.0 Micro Analysis Module2023-07-13 The Local Run Manager CF 139-Variant 2.0 Micro analysis module is for use with TruSight Cystic Fibrosis 139-Variant Assay when p
00816270020385 - Local Run Manager CF Clinical Seq 2.0 Micro Analysis Module2023-07-13 The Local Run Manager CF Clinical Seq 2.0 Micro analysis module is for use with TruSight Cystic Fibrosis Clinical Sequencing Ass
00816270020392 - Local Run Manager DNA GenerateFASTQ Dx Module for MiSeq™Dx2022-11-15 The Local Run Manager (LRM) DNA GenerateFASTQ Dx Module for MiSeq™Dx is used for sequencing run setup, run monitoring, and pri
00816270020415 - Local Run Manager DNA GenerateFASTQ Dx Module for NextSeq™ 550Dx2022-11-15 The Local Run Manager (LRM) DNA GenerateFASTQ Dx Module for NextSeq™ 550Dx is used for sequencing run setup, run monitoring, a
00816270020743 - DRAGEN™ for Illumina® DNA Prep with Enrichment Dx for NovaSeq™ 6000Dx2022-11-15 The DRAGEN™ for Illumina® DNA Prep with Enrichment Dx for NovaSeq™ 6000Dx application is used for sequencing run setup, ru
00816270020453 - Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set A (96 samples)2022-10-28 The Illumina® DNA Prep with Enrichment Dx Kit is a set of reagents and consumables used to prepare sample libraries from periph

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2017-06-07
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One Dome Global, Inc.
2017-05-10

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