FDA UDI
In Commercial Distribution
🇺🇸 United States
DHEA-S
DI: 00404847453478
·
Model: HYE-5347
·
DRG Instruments Gesellschaft mit beschränkter Haftung
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DHEA-S
- Primary DI
- 00404847453478
- Version / Model
- HYE-5347
- Catalog Number
- HYE-5347
- Company Name
- DRG Instruments Gesellschaft mit beschränkter Haftung
- Labeler DUNS
- 317134468
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-07
- Public Version
- 1
- Public Version Date
- 2021-06-15
- Public Version Status
- New
- Public Device Record Key
- 1e5459a0-3a01-47c4-aae4-b7c94262d1a9
Device Description
The DRG:Hybrid-XL DHEA-S is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of DHEA-S in serum and plasma.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JKC | RADIOIMMUNOASSAY, DEHYDROEPIANDROSTERONE (FREE AND SULFATE) | Clinical Chemistry | 862.1245 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63579 | Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of dehydroepiandrosterone sulfate (DHEAS) in a clinical specimen, using an enzyme immunoassay (EIA) method. It is used as an aid in the diagnosis of adrenal hyperplasia and hirsutism. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00404847453478 | GS1 |
Customer Contacts
- Phone
- +1(973)564-7555
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius