MiSeqDx CF 139 Variant Assay (2 Run) DX-102-1004

GUDID 00816270020019

The Illumina MiSeqDx Cystic Fibrosis 139-Variant Assay consists of library preparation and sample indexing reagents, sequencing reagents and consumables, MiSeqDx instrument and data analysis software. MiSeqDx Cystic Fibrosis 139 Variant Assay (2 Run) is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier: 15041293 MiSeqDx Cystic Fibrosis 139 Variant Assay 1/5 15041291 MiSeqDx Cystic Fibrosis 139 Variant Assay 1A 15041292 MiSeqDx Cystic Fibrosis 139 Variant Assay 1B 15041294 MiSeqDx Cystic Fibrosis 139 Variant Assay 2/5 15041297 MiSeqDx Cystic Fibrosis 139 Variant Assay 3/5 15041295 MiSeqDx Cystic Fibrosis 139 Variant Assay 3A 15041296 MiSeqDx Cystic Fibrosis 139 Variant Assay 3B 15041298 MiSeqDx Cystic Fibrosis 139 Variant Assay Box 4/5 15041299 MiSeqDx Cystic Fibrosis 139 Variant Assay Box 5/5

ILLUMINA, INC.

Cystic fibrosis IVD, kit, multiplex

• Primary Device ID: 00816270020019
• NIH Device Record Key: bfe9f36f-8a87-4272-b154-ebfad24670e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MiSeqDx CF 139 Variant Assay (2 Run)
• Version Model Number: 15036580
• Catalog Number: DX-102-1004
• Company DUNS: 033305264
• Company Name: ILLUMINA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816270020019 [Primary]

FDA Product Code

• PFR: System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Mutations & Variants Panel Sequencing Detection

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-21

Devices Manufactured by ILLUMINA, INC.

• 00816270020262 - Local Run Manager CF Clinical Sequencing Analysis Module: 2023-07-13 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 Module: 2023-07-13 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 Module: 2023-07-13 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 Module: 2023-07-13 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™Dx: 2022-11-15 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™ 550Dx: 2022-11-15 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™ 6000Dx: 2022-11-15 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