Qmedix

Basic Information

• Brand Name: Qmedix
• Primary DI: 00850054026033
• Version / Model: DACD1669-15
• Catalog Number: 1669-15
• Company Name: Diagnostic Automation, Inc.
• Labeler DUNS: 878252071
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-13
• Public Version: 1
• Public Version Date: 2023-06-21
• Public Version Status: New
• Public Device Record Key: 29ac0b0f-080a-4b7a-b853-9580b01c54ed

Device Description

Qmedix Digoxin ELISA -The Quantitative Determination of Digoxin Concentration in Human Serum or Plasma by a Microplate Enzyme Immunoassay, Colorimetric.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• 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
LCS	Radioimmunoassay, Digoxin (125-I)	Clinical Toxicology	862.3320	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55324	Digoxin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850054026033	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]