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Estrone Sulfate RIA
EUDAMEDFDA UDIClass B (EU MDR)
Ref DSL5400Model Immunoassay DSL5400
Identity
- Trade Name
- Estrone Sulfate RIA EUDAMEDEstrone-sulfate RIA FDA UDI
- Generic Name
- Estrone sulfate (oestrone sulfate) IVD, kit, radioimmunoassay FDA UDI
- Device Name
- Estrone Sulfate RIA EUDAMEDEstrone-sulfate RIA FDA UDI
- Model / Reference
- Immunoassay DSL5400 EUDAMEDDSL5400 EUDAMEDFDA UDI
- Description
- Estrone-sulfate RIA FDA UDI
Identifiers
- Catalog Number
- DSL5400 FDA UDI
- Primary DI / UDI-DI
- 15099590211547 EUDAMEDFDA UDI
- Basic UDI-DI
- 150995905DSL5400FA EUDAMED
- 510(k) Number
- K970915 FDA UDI
- FDA Product Code
- CGF FDA UDI
- EMDN Code
- W0102050204 ESTRONE EUDAMED
- GMDN Term
- Estrone sulfate (oestrone sulfate) 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 Sulfate 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 | 150995905DSL5400FA | 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 0c6809de-f9de-4f47-8c5c-6acc884215e3 61 fields · synced Jul 12, 2026
- FDA UDI 4622e79a-d589-4644-94df-68149ff87033 35 fields · synced May 29, 2026