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ACTIVE® Aldosterone RIA
EUDAMEDFDA UDIClass B (EU MDR)
Ref DSL8600Model Immunoassay, DSL8600
Identity
- Trade Name
- ACTIVE® Aldosterone RIA EUDAMEDACTIVE Aldosterone RIA FDA UDI
- Generic Name
- Aldosterone IVD, kit, radioimmunoassay FDA UDI
- Device Name
- ACTIVE® Aldosterone RIA EUDAMEDRadioimmunoassay Kit for the quantitative measurement of aldosterone in human serum, plasma or urine. FDA UDI
- Model / Reference
- Immunoassay, DSL8600 EUDAMEDDSL8600 EUDAMEDFDA UDI
- Description
- Radioimmunoassay Kit for the quantitative measurement of aldosterone in human serum, plasma or urine. FDA UDI
Identifiers
- Catalog Number
- DSL8600 FDA UDI
- Primary DI / UDI-DI
- 15099590211592 EUDAMEDFDA UDI
- Basic UDI-DI
- 150995905DSL8600G9 EUDAMED
- 510(k) Number
- K943397 FDA UDI
- FDA Product Code
- CJM FDA UDI
- EMDN Code
- W0102060201 ALDOSTERONE EUDAMED
- GMDN Term
- Aldosterone IVD, kit, radioimmunoassay FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1045 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
ACTIVE® Aldosterone 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 | 150995905DSL8600G9 | 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 01789334-ebad-47ba-9ab3-9c8e2a9ee5f8 61 fields · synced Jul 25, 2026
- FDA UDI 9d2fe13b-ded0-4b6a-8acf-4d736b7460d5 35 fields · synced May 30, 2026