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Estrone RIA
EUDAMEDFDA UDIClass B (EU MDR)
Ref DSL8700Model Immunoassay DSL8700
Identity
- Trade Name
- Estrone RIA EUDAMEDFDA UDI
- Generic Name
- Estrone (oestrone) IVD, kit, radioimmunoassay FDA UDI
- Device Name
- Estrone RIA EUDAMEDFDA UDI
- Model / Reference
- Immunoassay DSL8700 EUDAMEDDSL8700 EUDAMEDFDA UDI
- Description
- Estrone RIA FDA UDI
Identifiers
- Catalog Number
- DSL8700 FDA UDI
- Primary DI / UDI-DI
- 15099590211615 EUDAMEDFDA UDI
- Basic UDI-DI
- 150995905DSL8700GE EUDAMED
- 510(k) Number
- K935013 FDA UDI
- FDA Product Code
- CGF FDA UDI
- EMDN Code
- W0102050204 ESTRONE EUDAMED
- GMDN Term
- Estrone (oestrone) IVD, kit, radioimmunoassay FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1280 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
Estrone 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 | 150995905DSL8700GE | 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 6b96ecdd-2b34-47ed-9014-095e2a2f0d28 61 fields · synced Jul 31, 2026
- FDA UDI 5889863b-88e6-4455-9161-c048a5e469a5 35 fields · synced May 30, 2026