Access Digoxin Calibrators

Basic Information

• Brand Name: Access Digoxin Calibrators
• Primary DI: 15099590225780
• Version / Model: 33715
• Catalog Number: 33715
• Company Name: Beckman Coulter, Inc.
• Labeler DUNS: 008254708
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-09
• Public Version: 3
• Public Version Date: 2018-04-09
• Public Version Status: Update
• Public Device Record Key: cb19f2bd-956f-4683-a140-4dfc3d681ad2

Device Description

The Access Digoxin Calibrators are intended to calibrate the Access Digoxin assay for the Quantitative determination of digoxin levels in human serum using the Access Immunoassay Systems.

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KXT	Enzyme Immunoassay, Digoxin	Clinical Toxicology	862.3320	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55326	Digoxin therapeutic drug monitoring IVD, kit, chemiluminescent assay	A collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the cardiovascular drug digoxin in a clinical specimen, using a chemiluminescent method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15099590225780	GS1