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RevoDx Moraxella catarrhalis/ Haemophilus influenzae/ Streptococcus pyogenes qP…
EUDAMEDClass IVD General (EU MDR)
Ref IP202451-24Ref IP202313-100
Identity
- Trade Name
- RevoDx Moraxella catarrhalis/ Haemophilus influenzae/ Streptococcus pyogenes qPCR Kit EUDAMEDRevoDx Streptococcus pyogenes qPCR Kit EUDAMED
- Device Name
- RevoDx Moraxella catarrhalis/ Haemophilus influenzae/ Streptococcus pyogenes qPCR Kit EUDAMEDRevoDx Streptococcus pyogenes qPCR Kit EUDAMED
- Model / Reference
- IP202451-24 EUDAMEDIP202313-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684387212519 EUDAMED08684387212571 EUDAMED
- Basic UDI-DI
- B-08684387212519 EUDAMEDB-08684387212571 EUDAMED
- EMDN Code
- W0105070503 RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS EUDAMEDW0105011103 STREP. A DETECTION BY 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 Moraxella catarrhalis/ Haemophilus influenzae/ Streptococcus pyogenes qP… 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-08684387212519 | 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 807d9f37-7246-4a35-9d8b-02a6f35350b9 61 fields · synced Oct 6, 2026
- EUDAMED cea08e55-e23b-42cc-9e2d-3902f1466452 61 fields · synced May 19, 2026