Identity
- Trade Name
- DHEA-S FDA UDI
- Generic Name
- Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The DRG:Hybrid-XL DHEA-S is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of DHEA-S in serum and plasma. FDA UDI
- Model / Reference
- HYE-5347 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- HYE-5347 FDA UDI
- Primary DI / UDI-DI
- 00840239053473 FDA UDI
- FDA Product Code
- JKC FDA UDI
- GMDN Term
- Dehydroepiandrosterone sulfate (DHEAS) 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 sulfate (DHEAS) IVD, kit, enzyme immunoassay (EIA)
Dhea-S by DRG International, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- DHEA-S — DRG Instruments Gesellschaft mit beschränkter Haftung · Class I
- Dehydroepiandrosterone Sulfate (DHEA-S) ELISA — American Laboratory Products Company · Class I
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 7b0d8e9c-308e-4c34-9279-8fe4d8085c0c 36 fields · synced May 30, 2026