Identity
- Trade Name
- DHEA-S ELISA EUDAMEDFDA UDI
- Generic Name
- Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- DHEA-S ELISA EUDAMEDDHEA-S ELISA - 96 Determinations FDA UDI
- Model / Reference
- RE52181 EUDAMEDFDA UDI
- Description
- DHEA-S ELISA - 96 Determinations FDA UDI
Identifiers
- Catalog Number
- RE52181 FDA UDI
- Primary DI / UDI-DI
- 04049325001787 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04049325001787 EUDAMED
- FDA Product Code
- JKC FDA UDI
- EMDN Code
- W0102050102 DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA) EUDAMED
- GMDN Term
- Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1245 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Human Tissues
Yes
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, enzyme immunoassay (EIA)
Dhea-S Elisa by IBL International GmbH — Class I — IVDD, IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, enzyme immunoassay (EIA).
- DHEA-S — DRG International, Inc. · Class I
- DHEA-S ELISA — American Laboratory Products Company · Class I
- DHEA-S AccuBind ELISA Test System - 96 Wells — MONOBIND, INC. · Class I
- DHEA-S AccuBind ELISA Test System - 192 Wells — MONOBIND, INC. · Class I
- DHEA-S — DRG Instruments Gesellschaft mit beschränkter Haftung · Class I
- Dehydroepiandrosterone Sulfate (DHEA-S) ELISA — American Laboratory Products Company · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class I | Unknown |
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- IBL International GmbH
Sources (2)
- FDA UDI a8e6bbe2-39f6-4bfa-8442-d16ea657f249 36 fields · synced Jul 13, 2026
- EUDAMED f25a2546-a5c3-4f84-9c53-e63accc8e085 61 fields · synced Jul 13, 2026