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LyoSens HSV-1/HSV-2 qPCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref LYO139Model LYO139WS96
Identity
- Trade Name
- LyoSens HSV-1/HSV-2 qPCR Kit EUDAMED
- Device Name
- HSV-1/HSV-2 qPCR Kit EUDAMED
- Model / Reference
- LYO139WS96 EUDAMEDLYO139 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08685115806918 EUDAMED
- Basic UDI-DI
- B-08685115806918 EUDAMED
- EMDN Code
- W0105040311 HSV - NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany 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
LyoSens HSV-1/HSV-2 qPCR Kit by Vitrosens Biotechnology Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-08685115806918 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Vitrosens Biotechnology Inc.
- EUDAMED SRN
- TR-MF-000026452
Sources (1)
- EUDAMED 820c68cc-c169-47f0-857f-ecf90fe58b41 61 fields · synced Aug 4, 2026