| Primary Device ID | 04048474053494 |
| NIH Device Record Key | 312c0d97-fd7f-41d3-95ca-c17e07d6714f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Estradiol |
| Version Model Number | HYE-5349 |
| Catalog Number | HYE-5349 |
| 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 | |
| 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 |
| 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 | 04048474053494 [Primary] |
| CHP | Radioimmunoassay, Estradiol |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-11 |
| Device Publish Date | 2023-09-01 |
| 00404847453492 | The DRG:Hybrid-XL Estradiol is an enzyme immunoassay for the quantitative in vitro diagnostic me |
| 04048474053494 | The DRG:Hybrid-XL Estradiol is an enzyme immunoassay for the quantitative in vitro diagnostic me |