| Primary Device ID | 00840239052834 |
| NIH Device Record Key | b302adaa-46d0-4901-a751-0da584bccfa7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Thyrotropin (TSH) ELISA |
| Version Model Number | EIA-5283 |
| Catalog Number | EIA-5283 |
| Company DUNS | 075150847 |
| Company Name | DRG International 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 | 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 | 1 973-564-7555 |
| corpoffice@drg-international.com | |
| Phone | 1 973-564-7555 |
| corpoffice@drg-international.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840239052834 [Primary] |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-04 |
| Device Publish Date | 2023-08-25 |
| 00840239041111 | The Quantitative Determination of Thyrotropin Concentration in Human Serum by a Microplate Immun |
| 00840239052834 | The Quantitative Determination of Thyrotropin Concentration in Human Serum by a Microplate Immun |