Identity
- Trade Name
- DHEA RIA EUDAMEDFDA UDI
- Generic Name
- Dehydroepiandrosterone (DHEA) IVD, kit, radioimmunoassay FDA UDI
- Device Name
- DHEA RIA EUDAMEDFDA UDI
- Model / Reference
- Immunoassay DSL8900 EUDAMEDDSL8900 EUDAMEDFDA UDI
- Description
- DHEA RIA FDA UDI
Identifiers
- Catalog Number
- DSL8900 FDA UDI
- Primary DI / UDI-DI
- 15099590211622 EUDAMEDFDA UDI
- Basic UDI-DI
- 150995905DSL8900GQ EUDAMED
- 510(k) Number
- K921534 FDA UDI
- FDA Product Code
- JLK FDA UDI
- EMDN Code
- W0102050102 DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA) EUDAMED
- GMDN Term
- Dehydroepiandrosterone (DHEA) IVD, kit, radioimmunoassay FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1320 FDA UDI
- Market of Registration
- Czechia EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dhea Ria by IMMUNOTECH s.r.o. — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 150995905DSL8900GQ | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- IMMUNOTECH s.r.o.
- EUDAMED SRN
- CZ-MF-000001761
Sources (2)
- EUDAMED 11a2c3a7-8c3e-410a-af15-4f5c938760c6 61 fields · synced Jul 9, 2026
- FDA UDI 767f054b-af4b-4f99-9b27-15721e6bbe16 35 fields · synced May 29, 2026