125I TSH Receptor Antibody Kit (TRAb PEG) (With Ca KR6145

GUDID B126KR61450

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 Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, radioimmunoassay
Primary Device IDB126KR61450
NIH Device Record Keye5007d78-f81b-412a-aba4-fd557a60fa52
Commercial Distribution StatusIn Commercial Distribution
Brand Name125I TSH Receptor Antibody Kit (TRAb PEG) (With Ca
Version Model NumberKR6145
Catalog NumberKR6145
Company DUNS181070814
Company NameKRONUS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-457-6687
Emailkronus@kronus.com
Phone800-457-6687
Emailkronus@kronus.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB126KR61450 [Primary]

FDA Product Code

JZOSystem, Test, Thyroid Autoantibody

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-09-24
Device Publish Date2016-09-23

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

B126KR61650A radioimmunoassay for the quantitative or qualitative determination of antibodies to the thyroi
B126KR61450A radioimmunoassay for the quantitative or qualitative determination of antibodies to the thyroi
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