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RevoDx BK/JC Virus qPCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref IP202453-100Ref IP202453-25
Identity
- Trade Name
- RevoDx BK/JC Virus qPCR Kit EUDAMED
- Device Name
- RevoDx BK/JC Virus qPCR Kit EUDAMED
- Model / Reference
- IP202453-100 EUDAMEDIP202453-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684387213738 EUDAMED08684387213721 EUDAMED
- Basic UDI-DI
- B-08684387213738 EUDAMEDB-08684387213721 EUDAMED
- EMDN Code
- W0105040599 VIROLOGY - NA REAGENTS - OTHER EUDAMEDW0105040699 VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
RevoDx BK/JC Virus qPCR Kit by İdi̇l Bi̇otech Araştirma San. Ve Ti̇c. Ltd. Şti̇. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-08684387213738 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- İdi̇l Bi̇otech Araştirma San. Ve Ti̇c. Ltd. Şti̇.
- EUDAMED SRN
- TR-MF-000047330
Sources (2)
- EUDAMED 2eadef44-e863-4ab4-a331-37baa2024388 61 fields · synced Oct 7, 2026
- EUDAMED fb81f0fe-e9c8-477d-b8b8-0d00b86b2833 61 fields · synced May 18, 2026