Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2025560

FEI Number

2025560

Entity Name

KRONUS, INC.

City/State/Country

Star, ID, US

Establishment Address

170 S. Seneca Springs Way, Suite 105, Star, ID 83669, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

KRONUS, INC. (Owner Number: 2025560)

Owner / Operator Contact Address

170 S. Seneca Springs Way, SUITE 105, Star, ID 83669, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K863006

PMA Number

N/A

All Registered Proprietary Names

KRONUS GLUTAMIC ACID DEC Steroid 21-Hydroxylase Antibody (21-OHAb) RIA Assay Kit KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit KRONUS Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NWG	Autoantibodies, Glutamic Acid Decarboxylase (Gad)	Immunology	Class 2	866.5660	2006-04-05
PCG	21-Hydroxylase Antibody (21-Ohab)	Immunology	Class 2	866.5660	2012-12-21
PNI	Aquaporin-4 Autoantibody	Immunology	Class 2	866.5665	2016-08-14
NST	Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking	Immunology	Class 2	866.5660	2007-10-22
OIF	Tyrosine Phosphatase (Ia-2) Autoantibody Assay	Immunology	Class 2	866.5660	2008-06-05
JZO	System, Test, Thyroid Autoantibody	Immunology	Class 2	866.5870	2007-10-22
NST	Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking	Immunology	Class 2	866.5660	2008-10-28
OCN	Insulin Autoantibody Kit	Immunology	Class 2	866.5660	2007-10-22
PCG	21-Hydroxylase Antibody (21-Ohab)	Immunology	Class 2	866.5660	2018-12-05
NWG	Autoantibodies, Glutamic Acid Decarboxylase (Gad)	Immunology	Class 2	866.5660	2008-06-05
JZO	System, Test, Thyroid Autoantibody	Immunology	Class 2	866.5870	2007-10-22
PHF	Zinc Transporter 8 Auto-Antibody	Immunology	Class 2	866.5670	2014-09-12
OIF	Tyrosine Phosphatase (Ia-2) Autoantibody Assay	Immunology	Class 2	866.5660	2023-11-01
MSW	System, Test, Thyroglobulin	Immunology	Class 2	866.6010	2007-10-22
JZO	System, Test, Thyroid Autoantibody	Immunology	Class 2	866.5870	2007-10-22

Official Correspondent

HEATHER VIELE

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

KRONUS, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K000362	Zeus Scientific, Inc.	MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM	2000-02-18
K250250	Siemens Healthcare Diagnostics, Inc.	ADVIA Centaur Anti-Thyroid Peroxidase II	2025-10-17
K152061	Siemens Healthcare Diagnostics, Inc.	IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material	2016-03-03
K002888	Nichols Institute Diagnostics	NICHOLS ADVANTAGE THYROGLOB	2000-10-20

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2025560. Last updated year: 2026. Please use registration number 2025560 when referencing this establishment in official correspondence.