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GeneProof SARS-CoV-2 Advanced PCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref COV2A/GP/100
Identity
- Trade Name
- GeneProof SARS-CoV-2 Advanced PCR Kit EUDAMED
- Device Name
- GeneProof SARS-CoV-2 Advanced PCR Kit EUDAMED
- Model / Reference
- COV2A/GP/100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595696300760 EUDAMED
- Basic UDI-DI
- B-08595696300760 EUDAMED
- EMDN Code
- W0105041106 CORONAVIRUS - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Czechia 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
GeneProof SARS-CoV-2 Advanced PCR Kit is a cutting-edge medical device designed for advanced real-time PCR testing of SARS-CoV-2 infections. This IVD is suitable for professional testing and provides high-quality results, making it an essential tool in the diagnosis and management of COVID-19 cases. The GeneProof kit offers improved sensitivity, specificity, and speed compared to traditional methods, ensuring accurate diagnoses and effective treatment.
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-08595696300760 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- GeneProof a.s.
- EUDAMED SRN
- CZ-MF-000002370
Sources (1)
- EUDAMED be63c480-b24b-4cdd-b3de-f2998042ed80 61 fields · synced Jul 21, 2026