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RevoDx Parvovirus B19 Qualitative qPCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref IP202335-25Ref IP202335-100
Identity
- Trade Name
- RevoDx Parvovirus B19 Qualitative qPCR Kit EUDAMED
- Device Name
- RevoDx Parvovirus B19 Qualitative qPCR Kit EUDAMED
- Model / Reference
- IP202335-25 EUDAMEDIP202335-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684387213745 EUDAMED08684387213752 EUDAMED
- Basic UDI-DI
- B-08684387213745 EUDAMEDB-08684387213752 EUDAMED
- EMDN Code
- W0105040609 PARVOVIRUS B 19 EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Türkiye 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 Parvovirus B19 Qualitative qPCR Kit by İdi̇l Bi̇otech Araştirma San. Ve Ti̇c. Ltd. Şti̇. — Class IVD General — IVDD — listed in EUDAMED
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-08684387213745 | 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 b5b6d331-73ac-4b10-a39b-04587102a326 61 fields · synced Oct 8, 2026
- EUDAMED e6aba069-fc82-43fc-b195-ebe82235ddb7 61 fields · synced May 16, 2026