DIASTAT anti-thyroglobulin

Basic Information

• Brand Name: DIASTAT anti-thyroglobulin
• Primary DI: 07340058410110
• Version / Model: FATG200
• Catalog Number: FATG200
• Company Name: Euro-Diagnostica AB
• Labeler DUNS: 559894501
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-12
• Public Version: 6
• Public Version Date: 2023-10-18
• Public Version Status: Update
• Public Device Record Key: 4c86fa21-c26e-4fc0-be20-d99f2d78956f

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: Yes
• Has Donation ID: Yes

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
55209	Multiple thyroid 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 antibodies to the thyroid gland and/or specific products of thyroid gland metabolism in a clinical specimen, using an enzyme immunoassay (EIA) method. This test detects autoantibodies directed at antigens such as thyroid gland tissue, thyroglobulin, and thyroid peroxidase (TPO) [known as anti-microsomal antibody] to aid in the diagnosis of autoimmune thyroid diseases such as autoimmune thyroiditis (Hashimoto’s disease) and Graves’ disease.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07340058410110	GS1

Premarket Submissions

Submission Number	Supplement Number
K952183	000