| Primary Device ID | 04048474061017 | 
| NIH Device Record Key | e2754dbf-d84e-4210-9e3e-c6677aacea31 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Free Testosterone ELISA | 
| Version Model Number | EIA-6101 | 
| Catalog Number | EIA-6101 | 
| Company DUNS | 317134468 | 
| Company Name | DRG Instruments Gesellschaft mit beschränkter Haftung | 
| 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 | 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 | 04048474061017 [Primary] | 
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 
| 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 | 
| 04048474046380 | For the direct quantitative determination of Free Testosterone by enzyme immunoassay in human se | 
| 04048474061017 | The device is an Enzyme Immunoassay (EIA) for the quantitative measurement of free testosterone |