| Primary Device ID | 04048474040791 |
| NIH Device Record Key | 204af9b9-9aea-42e7-94fa-c9022fc947fa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Estrone ELISA |
| Version Model Number | EIA-4079 |
| Catalog Number | EIA-4079 |
| 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 | 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 | 973-564-7555 |
| corp@drg-international.com | |
| Phone | 973-564-7555 |
| corp@drg-international.com | |
| Phone | 973-564-7555 |
| corp@drg-international.com | |
| Phone | 973-564-7555 |
| corp@drg-international.com | |
| Phone | 973-564-7555 |
| corp@drg-international.com | |
| Phone | 973-564-7555 |
| corp@drg-international.com | |
| Phone | 973-564-7555 |
| corp@drg-international.com | |
| Phone | 973-564-7555 |
| corp@drg-international.com | |
| Phone | 973-564-7555 |
| corp@drg-international.com | |
| Phone | 973-564-7555 |
| corp@drg-international.com | |
| Phone | 973-564-7555 |
| corp@drg-international.com | |
| Phone | 973-564-7555 |
| corp@drg-international.com | |
| Phone | 973-564-7555 |
| corp@drg-international.com | |
| Phone | 973-564-7555 |
| corp@drg-international.com | |
| Phone | 973-564-7555 |
| corp@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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| 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 | 04048474040791 [Primary] |
| CGF | Radioimmunoassay, Estrone |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-08 |
| Device Publish Date | 2023-08-31 |
| 00404847441741 | The DRG Estrone ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurem |
| 04048474041743 | The DRG Estrone ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurem |
| 04048474040791 | For the direct quantitative determination of Estrone by enzyme immunoassay in human serum. |