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ACTIVE® Free Testosterone RIA
EUDAMEDFDA UDIFDA 510(k)Class B (EU MDR)
Ref DSL4900Model Immunoassay DSL4900
Identity
- Trade Name
- ACTIVE® Free Testosterone RIA EUDAMEDACTIVE Free Testosterone RIA FDA UDI
- Generic Name
- Free testosterone IVD, kit, radioimmunoassay FDA UDI
- Device Name
- ACTIVE® Free Testosterone RIA EUDAMEDACTIVE Free Testosterone RIA FDA UDI
- Model / Reference
- Immunoassay DSL4900 EUDAMEDDSL4900 EUDAMEDFDA UDI
- Description
- ACTIVE Free Testosterone RIA FDA UDI
Identifiers
- Catalog Number
- DSL4900 FDA UDI
- Primary DI / UDI-DI
- 15099590211530 EUDAMEDFDA UDI
- Basic UDI-DI
- 150995905DSL4900FU EUDAMED
- 510(k) Number
- K191350 FDA UDI
- FDA Product Code
- CDZ FDA UDI
- EMDN Code
- W0102050110 TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE) EUDAMED
- GMDN Term
- Free testosterone IVD, kit, radioimmunoassay FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 862.1680 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® Free Testosterone RIA by IMMUNOTECH s.r.o. — Class B — FDA_510K, IVDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191350 | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 150995905DSL4900FU | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- IMMUNOTECH s.r.o.
- EUDAMED SRN
- CZ-MF-000001761
Sources (3)
- EUDAMED 25cdd8df-9554-4530-abc3-e13c60de0175 61 fields · synced Jul 10, 2026
- FDA UDI 30af94a8-7ca1-453e-93f0-287e89df1546 35 fields · synced May 30, 2026
- FDA 510(k) K191350 1 fields · synced May 18, 2026