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.

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.
Access Digoxin Calibrators - 33715

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 Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 15099590225780

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