| Primary Device ID | 04260157080010 |
| NIH Device Record Key | 21c13f7b-292b-4db4-8aa4-797e66289e8c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ANTI-TG |
| Version Model Number | ORG502 |
| Catalog Number | ORG502 |
| Company DUNS | 328133103 |
| Company Name | ORGENTEC Diagnostika GmbH |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +49061319258 |
| BARBARA.MANSI@ORGENTEC.COM | |
| Phone | +49061319258 |
| BARBARA.MANSI@ORGENTEC.COM | |
| Phone | +49061319258 |
| BARBARA.MANSI@ORGENTEC.COM | |
| Phone | +49061319258 |
| BARBARA.MANSI@ORGENTEC.COM | |
| Phone | +49061319258 |
| BARBARA.MANSI@ORGENTEC.COM | |
| Phone | +49061319258 |
| BARBARA.MANSI@ORGENTEC.COM | |
| Phone | +49061319258 |
| BARBARA.MANSI@ORGENTEC.COM | |
| Phone | +49061319258 |
| BARBARA.MANSI@ORGENTEC.COM | |
| Phone | +49061319258 |
| BARBARA.MANSI@ORGENTEC.COM | |
| Phone | +49061319258 |
| BARBARA.MANSI@ORGENTEC.COM | |
| Phone | +49061319258 |
| BARBARA.MANSI@ORGENTEC.COM | |
| Phone | +49061319258 |
| BARBARA.MANSI@ORGENTEC.COM | |
| Phone | +49061319258 |
| BARBARA.MANSI@ORGENTEC.COM | |
| Phone | +49061319258 |
| BARBARA.MANSI@ORGENTEC.COM | |
| Phone | +49061319258 |
| BARBARA.MANSI@ORGENTEC.COM | |
| Phone | +49061319258 |
| BARBARA.MANSI@ORGENTEC.COM | |
| Phone | +49061319258 |
| BARBARA.MANSI@ORGENTEC.COM | |
| Phone | +49061319258 |
| BARBARA.MANSI@ORGENTEC.COM |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04260157080010 [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 | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-08-31 |
| 00198168683255 - Micro-Albumin | 2023-12-22 Micro-Albumin is a competitive ELISA test system for the quantitative measurement of human albumin in urine. This product is in |
| 04260157080010 - ANTI-TG | 2018-07-06ANTI-TG IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST THYROGLOBULIN (TG) IN HUMAN SERUM OR PLASMA. THI |
| 04260157080010 - ANTI-TG | 2018-07-06 ANTI-TG IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST THYROGLOBULIN (TG) IN HUMAN |
| 04260157080027 - ANTI-TPO | 2018-07-06 ANTI-TPO IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST THYROID PEROXIDASE (TPO) I |
| 04260157080034 - ENASCREEN | 2018-07-06 ENASCREEN IS AN ELISA TEST SYSTEM FOR THE QUALITATIVE SCREENING OF IgG CLASS AUTOANTIBODIES AGAINST EXTRACABLE NUCLEAR ANTIGENS |
| 04260157080058 - ANTI-SS-A | 2018-07-06 ANTI-SS-A IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST SS-A (52 AND 60kDa) IN HU |
| 04260157080065 - ANTI-SS-B | 2018-07-06 ANTI-SS-B IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST SS-B (La) IN HUMAN SERUM |
| 04260157080072 - ANTI-SM | 2018-07-06 ANTI-SM IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST SM IN HUMAN SERUM OR PLASMA |
| 04260157080089 - ANTI-RPN/SM | 2018-07-06 ANTI-RPN/SM IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST RNP/SM IN HUMAN SERUM O |