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 IdentifiersDevice 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