| Primary Device ID | B126KR71100 |
| NIH Device Record Key | 871bcf2e-3e3f-4b51-870e-5e0cc452b33c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KRONUS TSH RECEPTOR AUTOANTIBODY (TRAb) ELISA ASSA |
| Version Model Number | KR7110 |
| Catalog Number | KR7110 |
| Company DUNS | 181070814 |
| Company Name | KRONUS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 800-457-6687 |
| kronus@kronus.com | |
| Phone | 800-457-6687 |
| kronus@kronus.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B126KR71100 [Primary] |
| JZO | System, Test, Thyroid Autoantibody |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-23 |
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| B126KR61450 - 125I TSH Receptor Antibody Kit (TRAb PEG) (With Ca | 2018-09-24 A radioimmunoassay for the quantitative or qualitative determination of antibodies to the thyroid stimulating hormone (TSH) rece |
| B126KR61600 - 125I TSH Receptor Antibody Kit (TRAb PEG) (No Cali | 2018-09-24 A radioimmunoassay for the qualitative determination of antibodies to the thyroid stimulating hormone (TSH) receptor in human se |
| B126KR61650 - 125I TSH Receptor Antibody Kit (TRAb PEG) (With Ca | 2018-09-24 A radioimmunoassay for the quantitative or qualitative determination of antibodies to the thyroid stimulating hormone (TSH) rece |
| B126KR70600 - TSH RECEPTOR ANTIBODY (TRAb) COATED TUBE (CT) ASSA | 2018-09-24 A radioimmunoassay for the quantitative or qualitative determination of antibodies to the thyroid stimulating hormone (TSH) rece |
| B126KR71200 - TSH RECEPTOR ANTIBODY (TRAb) COATED TUBE (CT) ASSA | 2018-09-24 A radioimmunoassay for the quantitative or qualitative determination of antibodies to the thyroid stimulating hormone (TSH) rece |
| B126KR60100 - STEROID 21-HYDROXYLASE ANTIBODY (21-OHAb) RIA ASSA | 2018-07-06 A radioimmunoassay for the semi-quantitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. |