For the quantitative in vitro determination of Digoxin in human serum
DG - TD3410
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 an enzyme immunoassay (EIA) method.
Environmental Conditions
- Do not freeze
- 8.00
- 2.00
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: 05055273206425
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