FDA.reportPublic FDA data

KRONUS TSH RECEPTOR AUTOANTIBODY (TRAb) ELISA ASSAY KIT

Primary DI
B126KR71100
Brand
KRONUS TSH RECEPTOR AUTOANTIBODY (TRAb) ELISA ASSAY KIT
Company
KRONUS, INC.
Model
KR7110
Catalog number
KR7110
Device description
An enzyme linked immunosorbent assay for the semi-quantitative 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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B126KR71100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
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.

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
B126KR71200TSH RECEPTOR ANTIBODY (TRAb) COATED TUBE (CT) ASSAY KITKR7120KR71202016-09-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613336217641Elecsys Anti-TSHRRoche Diagnostics GmbHJZO2026-06-01
00630414245317Atellica IM Anti-Thyroglobulin II (aTgII)SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJZO2026-02-04
00630414245324Atellica IM Anti-Thyroglobulin II (aTgII)SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJZO2026-02-04
00630414245355ADVIA Centaur Anti-Thyroglobulin II (aTgII)SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJZO2026-02-04
00630414245362ADVIA Centaur Anti-Thyroglobulin II (aTgII)SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJZO2026-02-04
00630414608754Atellica IM aTPOIISIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJZO2026-01-26
00630414608761Atellica IM aTPOIISIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJZO2026-01-26
00630414609492Atellica IM aTPOII DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJZO2026-01-26
00630414608570ADVIA Centaur aTPOIISIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJZO2025-11-21
00630414608747ADVIA Centaur aTPOIISIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJZO2025-11-21
00630414609409ADVIA Centaur aTPOII DiluentSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDJZO2025-11-21
15099590763527Access Thyroglobulin Antibody IIBeckman Coulter, Inc.JZO2023-12-01
07613336171479Elecsys Anti-TgRoche Diagnostics GmbHJZO2023-10-31
07613336203521Elecsys Anti-TgRoche Diagnostics GmbHJZO2023-10-31
04048474033694TSH Receptor Autoantibody ELISA DRG Instruments Gesellschaft mit beschränkter HaftungJZO2023-08-29
00840239037084Anti TG Ab ELISADRG International IncJZO2023-08-25
00840239033697TSH Receptor Autoantibody ELISA DRG International IncJZO2023-08-24
00840239035615Anti TPO Ab ELISADRG International IncJZO2023-08-24
B3507204500Gold Standard Diagnostics Is-Anti-TPO IgG ELISA Test KitGold Standard Diagnostics CorporationJZO2022-12-03
B3507204600Gold Standard Diagnostics Is-Anti-TG IgG ELISA Test KitGold Standard Diagnostics CorporationJZO2022-12-03
00813545026721MeDiCaSCIMEDX CORPORATIONJZO2020-12-01
00813545026738MeDiCaSCIMEDX CORPORATIONJZO2020-12-01
00813545026745MeDiCaSCIMEDX CORPORATIONJZO2020-12-01
00813545026752MeDiCaSCIMEDX CORPORATIONJZO2020-12-01
00813545027148MeDiCaSCIMEDX CORPORATIONJZO2020-12-01
00813545027155MeDiCaSCIMEDX CORPORATIONJZO2020-12-01
00813545027162MeDiCaSCIMEDX CORPORATIONJZO2020-12-01
00813545027179MeDiCaSCIMEDX CORPORATIONJZO2020-12-01
07613336160305Elecsys Anti-TSHRRoche Diagnostics GmbHJZO2020-04-14
07613336160329Elecsys Anti-TSHRRoche Diagnostics GmbHJZO2020-04-14