FDA.reportPublic FDA data

KRONUS GLUTAMIC ACID DECARBOXYLASE RIA ANTIBODY KIT

Primary DI
B126KR67100
Brand
KRONUS GLUTAMIC ACID DECARBOXYLASE RIA ANTIBODY KIT
Company
KRONUS, INC.
Model
KR6710
Catalog number
KR6710
Device description
An enzyme linked immunosorbent assay for the semi-quantitative determination of glutamic acid decarboxylase (GAD) antibody 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
NWGAutoantibodies, Glutamic Acid Decarboxylase (Gad)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWGAutoantibodies, Glutamic Acid Decarboxylase (Gad)Immunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051061000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051061000KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KITKronus Market Development Associates, Inc.2005-11-04NWG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B126KR67100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Glutamic acid decarboxylase antibody (anti-GAD) IVD, kit, radioimmunoassayA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to glutamic acid decarboxylase (anti-GAD) in a clinical specimen, using a radioimmunoassay 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
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
B126KR65900KRONUS BINDING ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAb) ASSAY KIT KR6590KR65902016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048474040876GAD65 Ab ELISADRG Instruments Gesellschaft mit beschränkter HaftungNWG2024-12-02
B126KR77100KRONUS GLUTAMIC ACID DECARBOXYLASE AUTOANTIBODY ELISA ASSAY KITKRONUS, INC.NWG2016-09-23