Access Digoxin

Basic Information

• Brand Name: Access Digoxin
• Primary DI: 15099590225797
• Version / Model: 33710
• Catalog Number: 33710
• 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: abe9699e-0ea3-41b8-8025-2f9a5be73a45

Device Description

The Access Digoxin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of digoxin level in human serum ising the Access Immunoassay Systems.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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	15099590225797	GS1