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TaqPath™ Menu | GeneProof™ Hepatitis B Virus (HBV) PCR Kit
EUDAMEDClass IVD Annex II List A (EU MDR)
Ref A58426
Identity
- Trade Name
- TaqPath™ Menu | GeneProof™ Hepatitis B Virus (HBV) PCR Kit EUDAMED
- Device Name
- GeneProof Hepatitis B Virus (HBV) PCR Kit EUDAMED
- Model / Reference
- A58426 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595696304331 EUDAMED
- Basic UDI-DI
- B-08595696304331 EUDAMED
- EMDN Code
- W0105020216 HEPATITIS B VIRUS - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD Annex II List A 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
TaqPath™ Menu | GeneProof™ Hepatitis B Virus (HBV) PCR Kit by GeneProof a.s. — Class IVD Annex II List A — 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-08595696304331 | Class IVD Annex II List A | Active |
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Manufacturer
- Manufacturer
- GeneProof a.s.
- EUDAMED SRN
- CZ-MF-000002370
Sources (2)
- EUDAMED a0cf00c6-8713-462f-9a02-997ce0e71c7e 61 fields · synced Jul 16, 2026
- EUDAMED 315d380e-3bd8-449c-8b3c-c3b32a586563 61 fields · synced Jul 16, 2026