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LyoSense Salmonella spp. Detection qPCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref LYO04
Identity
- Trade Name
- LyoSense Salmonella spp. Detection qPCR Kit EUDAMED
- Device Name
- Salmonella spp. Detection qPCR Kit EUDAMED
- Model / Reference
- LYO04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683548259370 EUDAMED
- Basic UDI-DI
- B-08683548259370 EUDAMED
- EMDN Code
- W0105011003 SALMONELLA DETECTION BY 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
Yes
EUDAMED
Surgical Instrument
Yes
EUDAMED
LyoSense Salmonella spp. Detection 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-08683548259370 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Vitrosens Biotechnology Inc.
- EUDAMED SRN
- TR-MF-000026452
Sources (1)
- EUDAMED f0f700da-977a-47f7-8656-efe7ecbc0c95 61 fields · synced Aug 3, 2026