AccessGUDID - DEVICE: eSensor® XT-8 (00857167005160)

GUDID

Device Identifier (DI) Information

Brand Name: eSensor® XT-8
Version or Model: eSensor® Cystic Fibrosis (CF)
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: MT002014
Company Name: GENMARK DIAGNOSTICS, INC.

Primary DI Number: 00857167005160
Issuing Agency: GS1
Commercial Distribution End Date: August 14, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 962104217 *Terms of Use

Device Description: eSensor® Cystic Fibrosis Genotyping Test Amplification Reagents (CF) (24)

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
No Product Codes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: a4940ee0-0409-48e3-8499-8e9b3a753151
Public Version Date: August 15, 2023
Public Version Number: 3
DI Record Publish Date: September 24, 2016