Local Run Manager CF Clinical Sequencing Analysis Module

Basic Information

• Brand Name: Local Run Manager CF Clinical Sequencing Analysis Module
• Primary DI: 00816270020262
• Version / Model: 20046734
• Catalog Number: 20046734
• Company Name: ILLUMINA, INC.
• Labeler DUNS: 033305264
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-15
• Public Version: 2
• Public Version Date: 2023-07-13
• Public Version Status: Update
• Public Device Record Key: 99293689-6db8-4fae-888a-29b1ff417b1b

Device Description

The Local Run Manager CF Clinical Sequencing analysis module is for use with Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay. The assay detects mutations in the protein coding regions and intron/exon boundaries of the cystic fibrosis transmembrane conductance regulator (CFTR) gene, including two large deletions and two-deep intronic mutations. The analysis module performs secondary analysis and report generation from sequencing runs that use the MiSeqDx Cystic Fibrosis Clinical Sequencing Assay.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PFS	System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection	Immunology	866.5900	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59365	Cystic fibrosis IVD, kit, multiplex	A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict one or multiple mutations associated with the inborn genetic disorder cystic fibrosis due to mutation in the cystic fibrosis conductance regulator (CFTR) gene, using a multiplex method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816270020262	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K132750	000