Diamedix

Basic Information

• Brand Name: Diamedix
• Primary DI: 00817273020402
• Version / Model: 720-830
• 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: b4fa414d-98dd-4602-a5d1-4faf02f28c1d

Device Description

"720-830 anti-β2 Glycoprotein I IgG/IgM 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
MSV	System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)	Immunology	866.5660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
30972	Echinococcus granulosus/E. multilocularis immunoglobulin G (IgG) antibody IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to the parasitic tapeworms Echinococcus granulosus and/or Echinococcus multilocularis, in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817273020402	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K013628	000

Storage Conditions

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