FDA.reportPublic FDA data

TSH RECEPTOR ANTIBODY (TRAb) COATED TUBE (CT) ASSAY KIT

Primary DI
B126KR71200
Brand
TSH RECEPTOR ANTIBODY (TRAb) COATED TUBE (CT) ASSAY KIT
Company
KRONUS, INC.
Model
KR7120
Catalog number
KR7120
Device description
A radioimmunoassay for the quantitative or qualitative determination of antibodies to the thyroid stimulating hormone (TSH) receptor in human serum.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JZOSystem, Test, Thyroid Autoantibody

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZOSystem, Test, Thyroid AutoantibodyImmunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032134000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032134000TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KITKronus Market Development Associates, Inc.2003-09-10JZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B126KR71200PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, radioimmunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to thyroid stimulating hormone receptor (TSHR), also known as thyrotropin receptor, in a clinical specimen using a radioimmunoassay method. It is used in the diagnosis of autoimmune thyroid disorders such as hyperthyroidism in Graves’ disease.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-457-6687kronus@kronus.com

Regulatory Flags#

DUNS number
181070814
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B126KR62100MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO)KR6210KR62102016-09-23
B126KR62150MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO)KR6215KR62152017-12-18
B126KR77550KRONUS IA-2 Autoantibody (IA-2Ab) ELISA KitKR7755KR77552018-03-22
B126KR70150KRONUS 21-OH Autoantibody (21-OH) ELISA KitKR7015KR70152023-06-09
B126KR67100KRONUS GLUTAMIC ACID DECARBOXYLASE RIA ANTIBODY KITKR6710KR67102016-09-23
B126KR77100KRONUS GLUTAMIC ACID DECARBOXYLASE AUTOANTIBODY ELISA ASSAY KITKR7710KR77102016-09-23
B126KR61400125I TSH Receptor Antibody Kit (TRAb PEG) (No Calibrators)KR6140KR61402016-09-23
B126KR61450125I TSH Receptor Antibody Kit (TRAb PEG) (With Calibrators)KR6145KR61452016-09-23
B126KR61600125I TSH Receptor Antibody Kit (TRAb PEG) (No Calibrators)KR6160KR61602016-09-23
B126KR61650125I TSH Receptor Antibody Kit (TRAb PEG) (With Calibrators)KR6165KR61652016-09-23
B126KR70600TSH RECEPTOR ANTIBODY (TRAb) COATED TUBE (CT) ASSAY KITKR7060KR70602016-09-23
B126KR60100STEROID 21-HYDROXYLASE ANTIBODY (21-OHAb) RIA ASSAY KITKR6010KR60102016-09-23
B126KR60150STEROID 21-HYDROXYLASE ANTIBODY (21-OHAb) RIA ASSAY KITKR6015KR60152016-09-23
B126KR77300Zinc Transporter 8 Auto-Antibody (ZnT8)KR7730KR77302016-09-23
B126KR82000Aquaporin-4 Auto-Antibody (AQP4Ab)KR8200KR82002016-09-23
B126KR62700ANTI-THYROGLOBULIN TEST KIT (TgAb)KR6270KR62702016-09-23
B126KR62750ANTI-THYROGLOBULIN TEST KIT (TgAb)KR6275KR62752016-09-23
B126KR65650KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KITKR6565KR65652016-09-23
B126KR65800KRONUS BINDING ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAb) ASSAY KIT KR6580KR65802016-09-23
B126KR65900KRONUS BINDING ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAb) ASSAY KIT KR6590KR65902016-09-23

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