AccessGUDID - DEVICE: MiSeqDx Cystic Fibrosis Clinical Sequencing Assay (6 Run) (00816270020026)

GUDID

Device Identifier (DI) Information

Brand Name: MiSeqDx Cystic Fibrosis Clinical Sequencing Assay (6 Run)
Version or Model: 15036620
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: DX-102-1001
Company Name: ILLUMINA, INC.

Primary DI Number: 00816270020026
Issuing Agency: GS1
Commercial Distribution End Date: January 30, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 033305264 *Terms of Use

Device Description: 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

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:	Yes
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
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Storage Environment Temperature: between 15 and 25 Degrees Celsius
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0e2913bc-ca16-413e-aefa-e6d935e4dd34
Public Version Date: January 31, 2023
Public Version Number: 4
DI Record Publish Date: September 21, 2016