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RevoDx Methicillin resistance (mecA/mecC) qPCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref IP202210-500Ref IP202210-100
Identity
- Trade Name
- RevoDx Methicillin resistance (mecA/mecC) qPCR Kit EUDAMED
- Device Name
- RevoDx Methicillin resistance (mecA/mecC) qPCR Kit EUDAMED
- Model / Reference
- IP202210-500 EUDAMEDIP202210-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684387213349 EUDAMED08684387213332 EUDAMED
- Basic UDI-DI
- B-08684387213349 EUDAMEDB-08684387213332 EUDAMED
- EMDN Code
- W0105070202 BLOOD STREAM INFECTION/SEPSIS (BACTERIA & FUNGI) - MULTIPLEX NA REAGENTS 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 Methicillin resistance (mecA/mecC) 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-08684387213349 | 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 bffc376e-3098-42c6-8c13-721ad623f6f7 61 fields · synced Oct 8, 2026
- EUDAMED 7c30ed6a-41ca-4e70-88da-8114334fe526 61 fields · synced May 19, 2026