AccessGUDID - DEVICE: Local Run Manager CF Clinical Seq 2.0 Micro Analysis Module (00816270020385)

GUDID

Device Identifier (DI) Information

Brand Name: Local Run Manager CF Clinical Seq 2.0 Micro Analysis Module
Version or Model: 20072974
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20072974
Company Name: ILLUMINA, INC.

Primary DI Number: 00816270020385
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 033305264 *Terms of Use

Device Description: The Local Run Manager CF Clinical Seq 2.0 Micro analysis module is for use with TruSight Cystic Fibrosis Clinical Sequencing Assay when processing 24–36 samples. 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 TruSight Cystic Fibrosis.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
PFS	System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K132750	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2e2cc402-2a47-4110-b5db-9e7b2e1d39a5
Public Version Date: July 13, 2023
Public Version Number: 2
DI Record Publish Date: June 15, 2023