KRONUS TSH RECEPTOR AUTOANTIBODY (TRAb) ELISA ASSAY KIT

Basic Information

• Brand Name: KRONUS TSH RECEPTOR AUTOANTIBODY (TRAb) ELISA ASSAY KIT
• Primary DI: B126KR71100
• Version / Model: KR7110
• Catalog Number: KR7110
• Company Name: KRONUS, INC.
• Labeler DUNS: 181070814
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 871bcf2e-3e3f-4b51-870e-5e0cc452b33c

Device Description

An enzyme linked immunosorbent assay for the semi-quantitative determination of antibodies to the thyroid stimulating hormone (TSH) receptor in human serum.

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
JZO	System, Test, Thyroid Autoantibody	Immunology	866.5870	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58948	Immunoglobulin G subclass (IgG subclass) 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 one or multiple immunoglobulin G subclasses (IgG subclasses) 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	B126KR71100	HIBCC

Customer Contacts

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