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

• 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