Diamedix

Basic Information

• Brand Name: Diamedix
• Primary DI: 00817273020273
• Version / Model: 720-460
• Company Name: DIAMEDIX CORPORATION
• Labeler DUNS: 151765328
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-20
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: a8f7bbe8-6acd-4b9c-969b-59525ee6a695

Device Description

"720-460 anti-TG IgG Test Kit"

Device Characteristics

• Single Use: No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JZO	System, Test, Thyroid Autoantibody	Immunology	866.5870	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52217	Echinococcus multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Echinococcus multilocularis in a clinical specimen using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Echinococcus multilocularis, a parasitic tapeworm associated with hydatid disease.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817273020273	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K984228	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius