FDA.reportPublic FDA data

KRONUS 21-OH Autoantibody (21-OH) ELISA Kit

Primary DI
B126KR70150
Brand
KRONUS 21-OH Autoantibody (21-OH) ELISA Kit
Company
KRONUS, INC.
Model
KR7015
Catalog number
KR7015
Device description
An enzyme linked immunosorbent assay for the qualitative determination of autoantibodies to steroid 21-hydroxylase (21-OH) in human serum.
Published
2023-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PCG21-Hydroxylase Antibody (21-Ohab)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PCG21-Hydroxylase Antibody (21-Ohab)Immunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180607000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180607000Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA KitKronus, Inc.2018-11-23PCG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B126KR70150PrimaryHIBCC0

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
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
B126KR65900KRONUS BINDING ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAb) ASSAY KIT KR6590KR65902016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
0084023905955021-Hydroxylase Autoantibody ELISADRG International IncPCG2023-08-26
B126KR60100STEROID 21-HYDROXYLASE ANTIBODY (21-OHAb) RIA ASSAY KITKRONUS, INC.PCG2016-09-23
B126KR60150STEROID 21-HYDROXYLASE ANTIBODY (21-OHAb) RIA ASSAY KITKRONUS, INC.PCG2016-09-23