| Primary Device ID | 00404847441611 |
| NIH Device Record Key | 851da935-1c9d-413c-8d8e-0eef5525ea01 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dopamine ELISA |
| Version Model Number | N/A |
| Catalog Number | EIA-4161 |
| Company DUNS | 317134468 |
| Company Name | DRG Instruments Gesellschaft mit beschränkter Haftung |
| 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 | 00404847441611 [Primary] |
| CHQ | CHROMATOGRAPHIC/FLUOROMETRIC METHOD, CATECHOLAMINES |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-06-14 |
| Device Publish Date | 2019-06-06 |
| 00404847446159 | Manual and automated enzyme immunoassay for the in-vitro diagnostic quantitative determination o |
| 00404847441611 | Enzyme Immunoassay for the quantitative determination of dopamine in plasma and urine. |
| 04048474046151 | Manual and automated enzyme immunoassay for the in-vitro diagnostic quantitative determination o |
| 04048474041613 | Enzyme Immunoassay for the quantitative determination of dopamine in plasma and urine. |