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Ultra-Sensitive Estradiol RIA
EUDAMEDFDA UDIClass B (EU MDR)
Ref DSL4800Model Immunoassay DSL4800
Identity
- Trade Name
- Ultra-Sensitive Estradiol RIA EUDAMEDFDA UDI
- Generic Name
- Estradiol (oestradiol) (E2) IVD, kit, radioimmunoassay FDA UDI
- Device Name
- Ultra-Sensitive Estradiol RIA EUDAMEDFDA UDI
- Model / Reference
- Immunoassay DSL4800 EUDAMEDDSL4800 EUDAMEDFDA UDI
- Description
- Ultra-sensitive Estradiol RIA FDA UDI
Identifiers
- Catalog Number
- DSL4800 FDA UDI
- Primary DI / UDI-DI
- 15099590211523 EUDAMEDFDA UDI
- Basic UDI-DI
- 150995905DSL4800FP EUDAMED
- 510(k) Number
- K953605 FDA UDI
- FDA Product Code
- CHP FDA UDI
- EMDN Code
- W0102050103 ESTRADIOL EUDAMED
- GMDN Term
- Estradiol (oestradiol) (E2) IVD, kit, radioimmunoassay FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1260 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
Ultra-Sensitive Estradiol 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 | 150995905DSL4800FP | 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 6f62ac28-eb4b-4c9e-ae6f-c3bef70e9f85 61 fields · synced Jul 18, 2026
- FDA UDI 9a84fcf3-81ed-488b-8c40-74bf8e7fcfa9 35 fields · synced May 29, 2026