125I TSH Receptor Antibody Kit (TRAb PEG) (With Ca KR6165

GUDID B126KR61650

A radioimmunoassay for the quantitative or qualitative determination of antibodies to the thyroid stimulating hormone (TSH) receptor in human serum.

KRONUS, INC.

Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, radioimmunoassay

• Primary Device ID: B126KR61650
• NIH Device Record Key: 6903b416-aabb-4b09-9d5b-5898cd513c39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 125I TSH Receptor Antibody Kit (TRAb PEG) (With Ca
• Version Model Number: KR6165
• Catalog Number: KR6165
• Company DUNS: 181070814
• Company Name: KRONUS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-457-6687
• Email: kronus@kronus.com
• Phone: 800-457-6687
• Email: kronus@kronus.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B126KR61650 [Primary]

FDA Product Code

• JZO: System, Test, Thyroid Autoantibody

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-09-24
• Device Publish Date: 2016-09-23

On-Brand Devices [125I TSH Receptor Antibody Kit (TRAb PEG) (With Ca]

• B126KR61650: A radioimmunoassay for the quantitative or qualitative determination of antibodies to the thyroi
• B126KR61450: A radioimmunoassay for the quantitative or qualitative determination of antibodies to the thyroi