Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set A (96 samples) 20051352

GUDID 00816270020453

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 20050038, Illumina® Unique Dual Index Dx Set A (96 Indexes).

ILLUMINA, INC.

Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD

• Primary Device ID: 00816270020453
• NIH Device Record Key: 12932a1a-352d-4f6a-b8f5-aa88318ea595
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set A (96 samples)
• Version Model Number: 20051352
• Catalog Number: 20051352
• Company DUNS: 033305264
• Company Name: ILLUMINA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-809-4566
• Email: techsupport@illumina.com
• Phone: 800-809-4566
• Email: techsupport@illumina.com
• Phone: 800-809-4566
• Email: techsupport@illumina.com
• Phone: 800-809-4566
• Email: techsupport@illumina.com
• Phone: 800-809-4566
• Email: techsupport@illumina.com
• Phone: 800-809-4566
• Email: techsupport@illumina.com
• Phone: 800-809-4566
• Email: techsupport@illumina.com
• Phone: 800-809-4566
• Email: techsupport@illumina.com
• Phone: 800-809-4566
• Email: techsupport@illumina.com
• Phone: 800-809-4566
• Email: techsupport@illumina.com
• Phone: 800-809-4566
• Email: techsupport@illumina.com
• Phone: 800-809-4566
• Email: techsupport@illumina.com
• Phone: 800-809-4566
• Email: techsupport@illumina.com
• Phone: 800-809-4566
• Email: techsupport@illumina.com
• Phone: 800-809-4566
• Email: techsupport@illumina.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and -15 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816270020453 [Primary]

FDA Product Code

• PFT: Reagents For Molecular Diagnostic Test Systems

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-28
• Device Publish Date: 2022-10-20

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• 00816270020453 - Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set A (96 samples): 2022-10-28The 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 20050038, Illumina® Unique Dual Index Dx Set A (96 Indexes).
• 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