Diamedix

Basic Information

• Brand Name: Diamedix
• Primary DI: 00817273020280
• Version / Model: 720-480
• 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: eb11f4cc-0925-4eb1-ba4c-2770b12b7cc5

Device Description

"720-480 anti-Cardiolipin Screen"

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
52697	Anti-E [RH0003] antibody screen IVD, control	A material containing antibodies to E red blood cell antigens [RH0003] from the Rhesus system intended to be used in immunohaematological testing of a clinical specimen to verify the performance of an antibody screening assay that is used for detecting red cell alloantibodies.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817273020280	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K983553	000

Storage Conditions

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