| Primary Device ID | 00840239052773 |
| NIH Device Record Key | 0a84ef23-0916-4552-ae08-608d87dd4005 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Free Triiodothyronine (fT3) ELISA |
| Version Model Number | EIA-5277 |
| Catalog Number | EIA-5277 |
| Company DUNS | 075150847 |
| Company Name | DRG International Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | +1(973)564-7555 |
| corp@drg-international.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840239052773 [Primary] |
| CDP | RADIOIMMUNOASSAY, TOTAL TRIIODOTHYRONINE |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-03-30 |
| Device Publish Date | 2019-06-10 |
| 00840239052773 | The Quantitative Determination of Free Triiodothyronine Concentration in Human Serum by a Microp |
| 00840239041074 | The Quantitative Determination of Free Triiodothyronine Concentration in Human Serum by a Microp |
| 00840239023858 | For the quantitative determination of Free Triiodothyronine (fT3) concentration in human serum |