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RevoDx Extended Spectrum Beta-Lactamases (ESBL) Genes (CTX-M, TEM, SHV) qPCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref IP202259-100
Identity
- Trade Name
- RevoDx Extended Spectrum Beta-Lactamases (ESBL) Genes (CTX-M, TEM, SHV) qPCR Kit EUDAMED
- Device Name
- RevoDx Extended Spectrum Beta-Lactamases (ESBL) Genes (CTX-M, TEM, SHV) qPCR Kit EUDAMED
- Model / Reference
- IP202259-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684387213400 EUDAMED
- Basic UDI-DI
- B-08684387213400 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 Extended Spectrum Beta-Lactamases (ESBL) Genes (CTX-M, TEM, SHV) qPCR Kit by İdi̇l Bi̇otech Araştirma San. Ve Ti̇c. Ltd. Şti̇. — Class IVD General…
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-08684387213400 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- İdi̇l Bi̇otech Araştirma San. Ve Ti̇c. Ltd. Şti̇.
- EUDAMED SRN
- TR-MF-000047330
Sources (1)
- EUDAMED a256feeb-1534-458b-b153-41d5777181b7 61 fields · synced Oct 7, 2026