Identity
- Trade Name
- DHEA-S-7 RIA EUDAMEDFDA UDI
- Generic Name
- Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, radioimmunoassay FDA UDI
- Device Name
- DHEA-S-7 RIA EUDAMEDFDA UDI
- Model / Reference
- DSL2700 EUDAMEDFDA UDI
- Description
- DHEA-S-7 RIA FDA UDI
Identifiers
- Catalog Number
- DSL2700 FDA UDI
- Primary DI / UDI-DI
- 15099590211509 EUDAMEDFDA UDI
- Basic UDI-DI
- 150995905DSL2700F4 EUDAMED
- 510(k) Number
- K962895 FDA UDI
- FDA Product Code
- JKC FDA UDI
- EMDN Code
- W0102039099 TUMOUR MARKERS - OTHER EUDAMED
- GMDN Term
- Dehydroepiandrosterone sulfate (DHEAS) IVD, kit, radioimmunoassay FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1245 FDA UDI
- Market of Registration
- Czechia EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Preferentially expressed antigen in melanoma (PRAME) IVD, antibody
Dhea-S-7 Ria by IMMUNOTECH s.r.o. — Class C — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/IVDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 150995905DSL2700F4 | Class C | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class C | Pending data |
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Manufacturer
- Manufacturer
- IMMUNOTECH s.r.o.
- EUDAMED SRN
- CZ-MF-000001761
Sources (2)
- EUDAMED cd2b3b21-0f26-45e3-938c-c7758564ecea 61 fields · synced Jul 10, 2026
- FDA UDI 59bc44d7-96c3-4eed-b122-850112ca6df0 35 fields · synced May 30, 2026