Androstenedione HYE-5339
GUDID 00404847453393
The DRG:Hybrid-XL Androstenedione is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Androstenedione in serum.
DRG Instruments Gesellschaft mit beschränkter Haftung
Androstenedione IVD, kit, enzyme immunoassay (EIA) Androstenedione IVD, kit, enzyme immunoassay (EIA) Androstenedione IVD, kit, enzyme immunoassay (EIA) Androstenedione IVD, kit, enzyme immunoassay (EIA) Androstenedione IVD, kit, enzyme immunoassay (EIA) Androstenedione IVD, kit, enzyme immunoassay (EIA) Androstenedione IVD, kit, enzyme immunoassay (EIA) Androstenedione IVD, kit, enzyme immunoassay (EIA) Androstenedione IVD, kit, enzyme immunoassay (EIA) Androstenedione IVD, kit, enzyme immunoassay (EIA) Androstenedione IVD, kit, enzyme immunoassay (EIA) Androstenedione IVD, kit, enzyme immunoassay (EIA) Androstenedione IVD, kit, enzyme immunoassay (EIA) Androstenedione IVD, kit, enzyme immunoassay (EIA) Androstenedione IVD, kit, enzyme immunoassay (EIA) Androstenedione IVD, kit, enzyme immunoassay (EIA)| Primary Device ID | 00404847453393 |
| NIH Device Record Key | e101ada6-ea6f-4476-a8f6-3b35a711cb70 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Androstenedione |
| Version Model Number | HYE-5339 |
| Catalog Number | HYE-5339 |
| 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 | +1(973)564-7555 |
| corp@drg-international.com | |
| Phone | +1(973)564-7555 |
| corp@drg-international.com | |
| Phone | +1(973)564-7555 |
| corp@drg-international.com | |
| Phone | +1(973)564-7555 |
| corp@drg-international.com | |
| Phone | +1(973)564-7555 |
| corp@drg-international.com | |
| Phone | +1(973)564-7555 |
| corp@drg-international.com | |
| Phone | +1(973)564-7555 |
| corp@drg-international.com | |
| Phone | +1(973)564-7555 |
| corp@drg-international.com | |
| Phone | +1(973)564-7555 |
| corp@drg-international.com | |
| Phone | +1(973)564-7555 |
| corp@drg-international.com | |
| Phone | +1(973)564-7555 |
| corp@drg-international.com | |
| Phone | +1(973)564-7555 |
| corp@drg-international.com | |
| Phone | +1(973)564-7555 |
| corp@drg-international.com | |
| Phone | +1(973)564-7555 |
| corp@drg-international.com | |
| Phone | +1(973)564-7555 |
| corp@drg-international.com | |
| Phone | +1(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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00404847453393 [Primary] |
FDA Product Code
| CIZ | RADIOIMMUNOASSAY, ANDROSTENEDIONE |
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 | 2021-06-15 |
| Device Publish Date | 2021-06-07 |
On-Brand Devices [Androstenedione]
| 00404847453393 | The DRG:Hybrid-XL Androstenedione is an enzyme immunoassay for the quantitative in vitro diagnos |
| 04048474053395 | The DRG:Hybrid-XL Androstenedione is an enzyme immunoassay for the quantitative in vitro diagnos |
Trademark Results [Androstenedione]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ANDROSTENEDIONE 75305069 not registered Dead/Abandoned |
AST Research, Inc. 1997-06-09 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.