eSensor® XT-8

Basic Information

• Brand Name: eSensor® XT-8
• Primary DI: 00857167005146
• Version / Model: eSensor® Cystic Fibrosis (CF)
• Catalog Number: KT020657
• Company Name: GENMARK DIAGNOSTICS, INC.
• Labeler DUNS: 962104217
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2023-08-15
• Public Version Status: Update
• Public Device Record Key: 53d12d1b-0eb3-49b7-9aaa-08586de28e37
• Distribution End Date: 2023-08-14

Device Description

eSensor® Cystic Fibrosis Genotyping Test Cartridge Pouch (CF) (8)

Device Characteristics

• Single Use: Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

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	00857167005146	GS1