MiSeqDx Cystic Fibrosis Clinical Sequencing Assay (6 Run) DX-102-1001

GUDID 00816270020026

The Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay consists of library preparation and sample indexing reagents, sequencing reagents and consumables, MiSeqDx instrument and data analysis software. MiSeqDx Cystic Fibrosis Clinical Sequencing Assay is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier: 15035429 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 1/5 15038248 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 1A 15038249 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 1B 15035436 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 2/5 15035430 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 3/5 15038250 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 3A 15038251 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 3B 15036622 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 4/5 15036623 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 5/5

ILLUMINA, INC.

Cystic fibrosis IVD, kit, multiplex

• Primary Device ID: 00816270020026
• NIH Device Record Key: 0e2913bc-ca16-413e-aefa-e6d935e4dd34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MiSeqDx Cystic Fibrosis Clinical Sequencing Assay (6 Run)
• Version Model Number: 15036620
• Catalog Number: DX-102-1001
• 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 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816270020026 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132750

FDA Product Code

• PFS: System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence 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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

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