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RevoDx Direct SARS-CoV-2 qPCR Kit on 96/384-well plate (Extraction-free)
EUDAMEDClass IVD General (EU MDR)
Ref IP202221-96Ref IP202221-480Ref IP202221-384
Identity
- Trade Name
- RevoDx Direct SARS-CoV-2 qPCR Kit on 96/384-well plate (Extraction-free) EUDAMED
- Device Name
- RevoDx Direct SARS-CoV-2 qPCR Kit on 96/384-well plate (Extraction-free) EUDAMED
- Model / Reference
- IP202221-96 EUDAMEDIP202221-480 EUDAMEDIP202221-384 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684387210041 EUDAMED08684387210171 EUDAMED08684387210058 EUDAMED
- Basic UDI-DI
- B-08684387210041 EUDAMEDB-08684387210171 EUDAMEDB-08684387210058 EUDAMED
- EMDN Code
- W0105041106 CORONAVIRUS - NA REAGENTS 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 Direct SARS-CoV-2 qPCR Kit on 96/384-well plate (Extraction-free) by İdi̇l Bi̇otech Araştirma San. Ve Ti̇c. Ltd. Şti̇. — Class IVD General — IVDD…
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-08684387210041 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- İdi̇l Bi̇otech Araştirma San. Ve Ti̇c. Ltd. Şti̇.
- EUDAMED SRN
- TR-MF-000047330
Sources (3)
- EUDAMED 524fcc6e-c346-4d37-a111-bba18041a12e 61 fields · synced Oct 6, 2026
- EUDAMED e65e41bd-27a0-48a8-9a4c-19c30852d20c 61 fields · synced May 16, 2026
- EUDAMED 8fe9a862-35b1-4c4d-b679-72a7c94da924 61 fields · synced May 17, 2026