KRONUS, INC.

Matched from indexed company URL: Kronus, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20255602025560KRONUS, INC.1Y2026-01-01170 S. Seneca Springs Way Suite 105 Star ID US 83669

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
B126KR61400125I TSH Receptor Antibody Kit (TRAb PEG) (No Calibrators) - A radioimmunoassay for the qualitative determination of antibodies to the thyroid stimulating hormone (TSH) receptor in human serum.800-457-6687kronus@kronus.com
B126KR61450125I TSH Receptor Antibody Kit (TRAb PEG) (With Calibrators) - A radioimmunoassay for the quantitative or qualitative determination of antibodies to the thyroid stimulating hormone (TSH) receptor in human serum.800-457-6687kronus@kronus.com
B126KR62100MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO) - A radioimmunoassay for the quantitative or qualitative determination of antibodies to thyroid peroxidase (TPO) receptor in human serum.800-457-6687kronus@kronus.com
B126KR62150MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO) - A radioimmunoassay for the quantitative or qualitative determination of antibodies to thyroid peroxidase (TPO) receptor in human serum.800-457-6687kronus@kronus.com
B126KR67100KRONUS GLUTAMIC ACID DECARBOXYLASE RIA ANTIBODY KIT - An enzyme linked immunosorbent assay for the semi-quantitative determination of glutamic acid decarboxylase (GAD) antibody in human serum.800-457-6687kronus@kronus.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
345761231957950K991720KRONUS OPTIQUANT THYROGLOBULIN KITMSW1999-08-09
345761184503979K915429KRONUS KALIBRE THYROID PEROXIDASE ANTIBODY EIA KITJZO1992-03-30
345761132793144K915428KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KITJZO1992-03-30
345761032836116K894364MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO)JZO1989-07-25
345761978659029K894203ANTI-THYROGLOBULIN TEST KITJZO1989-07-25
345761142313239K863006125-I TSH RECEPTOR ANTIBODY KITJZO1986-09-08
345761290767743K220085KRONUS IA-2 Autoantibody (IA-2Ab) ELISA KitOIF2023-08-24
345761188567280K180607Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA KitPCG2018-11-23
345761371939443K171731KRONUS IA-2 Autoantibody (IA-2Ab) ELISA KitOIF2018-01-19
345761351536228K161951KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA AssayPNI2016-07-22
345762073585719K121046STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KITPCG2012-12-20
345761326939421K111956KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KITPAF2012-05-30
345761779889313K080523KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KITNST2008-06-17
345761211468766K080159KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KITJZO2008-05-22
345761319966421K073590KRONUS IA-2 AUTOANTIBODY RIA ASSAY KITOIF2008-04-10
345761632442649K072135KRONUS GAD AUTOANTIBODY ELISA ASSAY KITNWG2007-11-07
345761668249258K070183KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KITOCN2007-07-13
345761930318014K051061KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KITNWG2005-11-04
345761749712177K042248KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KITNST2004-12-17
345761071498066K032134TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KITJZO2003-09-10
345761089834532DEN140001ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KITPHF2014-08-20

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JZO72008-05-22
OIF32023-08-24
PCG22018-11-23
NST22008-06-17
NWG22007-11-07
PNI12016-07-22
PHF12014-08-20
PAF12012-05-30
OCN12007-07-13
MSW11999-08-09

PMN#

GUDID#