Identity
- Trade Name
- DHEA FDA UDI
- Generic Name
- Dehydroepiandrosterone (DHEA) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The DRG:Hybrid-XL DHEA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of DHEA in serum and plasma. FDA UDI
- Model / Reference
- HYE-5346 FDA UDI
- Description
- The DRG:Hybrid-XL DHEA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of DHEA in serum and plasma. FDA UDI
Identifiers
- Catalog Number
- HYE-5346 FDA UDI
- Primary DI / UDI-DI
- 00840239053466 FDA UDI
- FDA Product Code
- JKC FDA UDI
- GMDN Term
- Dehydroepiandrosterone (DHEA) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1245 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dehydroepiandrosterone (DHEA) IVD, kit, enzyme immunoassay (EIA)
Dhea by DRG International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- DRG International, Inc.
Sources (1)
- FDA UDI f67450e2-bd40-445e-b130-aa94b81ca223 36 fields · synced May 31, 2026