DHEA HYE-5346
GUDID 04048474053463
The DRG:Hybrid-XL DHEA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of DHEA in serum and plasma.
DRG Instruments Gesellschaft mit beschränkter Haftung
Dehydroepiandrosterone (DHEA) IVD, kit, enzyme immunoassay (EIA)| Primary Device ID | 04048474053463 |
| NIH Device Record Key | 33dd13d6-d7dd-43a5-956f-73294f518e24 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DHEA |
| Version Model Number | HYE-5346 |
| Catalog Number | HYE-5346 |
| 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 |
Customer Support Contacts
| 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 |
Operating and Storage Conditions
| 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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04048474053463 [Primary] |
FDA Product Code
| JKC | Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-11 |
| Device Publish Date | 2023-09-01 |
On-Brand Devices [DHEA]
| 00404847453461 | The DRG:Hybrid-XL DHEA is an enzyme immunoassay for the quantitative in vitro diagnostic measure |
| 04048474053463 | The DRG:Hybrid-XL DHEA is an enzyme immunoassay for the quantitative in vitro diagnostic measure |
Trademark Results [DHEA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DHEA 90899919 not registered Live/Pending |
Hong Kong Fu Mai Genetic Engineering Limited 2021-08-24 |
 DHEA 77174126 not registered Dead/Abandoned |
NutriCare Essentials, Inc. 2007-05-07 |
 DHEA 73058682 1032762 Dead/Expired |
SANDOZ, INC. 1975-07-25 |
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