Access Digoxin Calibrator S0

Basic Information

• Brand Name: Access Digoxin Calibrator S0
• Primary DI: 15099590225766
• Version / Model: 33716
• Catalog Number: 33716
• 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: ef226013-6852-4d1f-8944-f16c1810eeaf

Device Description

The Access Digoxin Calibrator S0 is intended for use with the Access Digoxin assay to dilute patient samples containing analyte concentrations greater than the analyte specific S5 calibrator.

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	15099590225766	GS1