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.


Product Overview

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.
Access Digoxin Calibrator S0 - 33716


Device Description

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.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available


Product Codes

Code: KXT

Device Name: Enzyme Immunoassay, Digoxin

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: TX

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 862.3320

Third Party Flag: Y

Medical Specialty: TX


Device Identifiers

Device Id: 15099590225766

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A


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