kronus.comKRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit
Kronus, Inc.
KRONUS, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2025560 | 2025560 | KRONUS, INC. | 1 | Y | 2026-01-01 | 170 S. Seneca Springs Way Suite 105 Star ID US 83669 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| B126KR61400 | 125I 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. | 800-457-6687 | kronus@kronus.com |
| B126KR61450 | 125I 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. | 800-457-6687 | kronus@kronus.com |
| B126KR62100 | MODIFIED 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. | 800-457-6687 | kronus@kronus.com |
| B126KR62150 | MODIFIED 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. | 800-457-6687 | kronus@kronus.com |
| B126KR67100 | KRONUS 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. | 800-457-6687 | kronus@kronus.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 34576 | 1231957950 | K991720 | KRONUS OPTIQUANT THYROGLOBULIN KIT | MSW | 1999-08-09 |
| 34576 | 1184503979 | K915429 | KRONUS KALIBRE THYROID PEROXIDASE ANTIBODY EIA KIT | JZO | 1992-03-30 |
| 34576 | 1132793144 | K915428 | KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KIT | JZO | 1992-03-30 |
| 34576 | 1032836116 | K894364 | MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO) | JZO | 1989-07-25 |
| 34576 | 1978659029 | K894203 | ANTI-THYROGLOBULIN TEST KIT | JZO | 1989-07-25 |
| 34576 | 1142313239 | K863006 | 125-I TSH RECEPTOR ANTIBODY KIT | JZO | 1986-09-08 |
| 34576 | 1290767743 | K220085 | KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit | OIF | 2023-08-24 |
| 34576 | 1188567280 | K180607 | Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit | PCG | 2018-11-23 |
| 34576 | 1371939443 | K171731 | KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit | OIF | 2018-01-19 |
| 34576 | 1351536228 | K161951 | KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay | PNI | 2016-07-22 |
| 34576 | 2073585719 | K121046 | STEROID 21-HYDROXYLASE ANTIBODY (21-OHAB) RIA ASSAY KIT | PCG | 2012-12-20 |
| 34576 | 1326939421 | K111956 | KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT | PAF | 2012-05-30 |
| 34576 | 1779889313 | K080523 | KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT | NST | 2008-06-17 |
| 34576 | 1211468766 | K080159 | KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT | JZO | 2008-05-22 |
| 34576 | 1319966421 | K073590 | KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT | OIF | 2008-04-10 |
| 34576 | 1632442649 | K072135 | KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT | NWG | 2007-11-07 |
| 34576 | 1668249258 | K070183 | KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT | OCN | 2007-07-13 |
| 34576 | 1930318014 | K051061 | KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT | NWG | 2005-11-04 |
| 34576 | 1749712177 | K042248 | KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KIT | NST | 2004-12-17 |
| 34576 | 1071498066 | K032134 | TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT | JZO | 2003-09-10 |
| 34576 | 1089834532 | DEN140001 | ZINC TRANSPORTER 8 ANTIBODY (ZNT8AB) ELISA ASSAY KIT | PHF | 2014-08-20 |
Product Codes Associated With Registrations#
PMN#
GUDID#
MODIFIED 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.
2016-09-23
MODIFIED 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.
2017-12-18
KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit - An enzyme linked immunosorbent assay for the quantitative determination of autoantibodies against tyrosine phosphatase (IA-2) in human serum
2018-03-22
KRONUS 21-OH Autoantibody (21-OH) ELISA Kit - An enzyme linked immunosorbent assay for the qualitative determination of autoantibodies to steroid 21-hydroxylase (21-OH) in human serum.
2023-06-09
KRONUS 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.
2016-09-23
KRONUS GLUTAMIC ACID DECARBOXYLASE AUTOANTIBODY ELISA ASSAY KIT - An enzyme linked immunosorbent assay for the semi-quantitative determination of glutamic acid decarboxylase (GAD) antibody in human serum.
2016-09-23
125I 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.
2016-09-23
125I 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.
2016-09-23
125I 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.
2016-09-23
125I 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.
2016-09-23
TSH RECEPTOR ANTIBODY (TRAb) COATED TUBE (CT) ASSAY KIT - A radioimmunoassay for the quantitative or qualitative determination of antibodies to the thyroid stimulating hormone (TSH) receptor in human serum.
2016-09-23
TSH RECEPTOR ANTIBODY (TRAb) COATED TUBE (CT) ASSAY KIT - A radioimmunoassay for the quantitative or qualitative determination of antibodies to the thyroid stimulating hormone (TSH) receptor in human serum.
2016-09-23
STEROID 21-HYDROXYLASE ANTIBODY (21-OHAb) RIA ASSAY KIT - A radioimmunoassay for the semi-quantitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum.
2016-09-23
STEROID 21-HYDROXYLASE ANTIBODY (21-OHAb) RIA ASSAY KIT - A radioimmunoassay for the semi-quantitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum.
2016-09-23
Zinc Transporter 8 Auto-Antibody (ZnT8) - An enzyme linked immunosorbent assay for the semi-quantitative determination of autoantibodies to Zinc Transporter 8 (ZnT8) in human serum.
2016-09-23
Aquaporin-4 Auto-Antibody (AQP4Ab) - An enzyme linked immunosorbent assay for the semi-quantitative determination of autoantibodies to Aquaporin-4 in human serum.
2016-09-23
ANTI-THYROGLOBULIN TEST KIT (TgAb) - A radioimmunoassay for the quantitative or qualitative determination of antibodies to thyroglobulin(Tg) in human serum.
2016-09-23
ANTI-THYROGLOBULIN TEST KIT (TgAb) - A radioimmunoassay for the quantitative or qualitative determination of antibodies to thyroglobulin(Tg) in human serum.
2016-09-23
KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT - The KRONUS VGCC Antibody RIA Assay Kit is a radioimmunoassay for the semi-quantitative determination of antibodies to voltage gated calcium channels (VGCC) in human serum.
2016-09-23
KRONUS BINDING ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAb) ASSAY KIT - A radioimmunoassay for the quantitative of qualitative determination ofantibodies to the acetylcholine receptor (AChR) in human serum.
2016-09-23
KRONUS BINDING ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAb) ASSAY KIT - A radioimmunoassay for the quantitative of qualitative determination ofantibodies to the acetylcholine receptor (AChR) in human serum.
2016-09-23
KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT - A radioimmunoassay for the semi-quantitative determination of antibodies to tyrosine phosphatase (IA-2) in human serum.
2016-09-23
KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT - A radioimmunoassay for the semi-quantitative determination of antibodies to insulin in human serum.
2016-09-23
KRONUS TSH RECEPTOR AUTOANTIBODY (TRAb) ELISA ASSAY KIT - An enzyme linked immunosorbent assay for the semi-quantitative determination of antibodies to the thyroid stimulating hormone (TSH) receptor in human serum.
2016-09-23
KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAb) RIA ASSAY KIT - A radioimmunoassay for the semi-quantitative determination of blocking antibodies to the acetylcholine receptor (AChR) in human serum.
2016-09-23