125I TSH Receptor Antibody Kit (TRAb PEG) (No Cali KR6140

GUDID B126KR61400

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

• Primary Device ID: B126KR61400
• NIH Device Record Key: 3831e564-a68b-4811-8850-62c6c2113e6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 125I TSH Receptor Antibody Kit (TRAb PEG) (No Cali
• Version Model Number: KR6140
• Catalog Number: KR6140
• 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	B126KR61400 [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) (No Cali]

• B126KR61600: A radioimmunoassay for the qualitative determination of antibodies to the thyroid stimulating ho
• B126KR61400: A radioimmunoassay for the qualitative determination of antibodies to the thyroid stimulating h