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LyoSens™ Francisella Tularensis Detection qPCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref LYO91Ref LYO28Ref PCR28Model LYO28WS24
Identity
- Trade Name
- LyoSens™ Francisella Tularensis Detection qPCR Kit EUDAMEDLyoSens Salmonella, Campylobacter & Shigella/EIEC Detection qPCR Kit EUDAMEDLyoSens™ EUDAMED
- Device Name
- LyoSens™ Francisella Tularensis Detection qPCR Kit EUDAMEDSalmonella, Campylobacter & Shigella/EIEC Detection qPCR Kit EUDAMEDSalmonella/Campylobacter/Shigella (EIEC) Genotyping qPCR Kit EUDAMED
- Model / Reference
- LYO91 EUDAMEDLYO28 EUDAMEDLYO28WS24 EUDAMEDPCR28 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08684595037508 EUDAMED08683548258823 EUDAMED
- Basic UDI-DI
- B-08684595037508 EUDAMEDB-08683548258823 EUDAMED
- EMDN Code
- W0105011699 BACTERIOLOGY - NA REAGENTS - OTHER EUDAMEDW0105011003,W0105011402,W0105011503,W0105011614 EUDAMEDW0105070504 GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Türkiye EUDAMEDGermany 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
EUDAMEDEUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
Yes
EUDAMEDEUDAMED
Surgical Instrument
No
EUDAMEDEUDAMED
LyoSens™ Francisella Tularensis 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-08684595037508 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Vitrosens Biotechnology Inc.
- EUDAMED SRN
- TR-MF-000026452
Sources (3)
- EUDAMED 1d47e71e-1e17-4ee5-a547-4f43428fe04f 61 fields · synced Oct 7, 2026
- EUDAMED b0dfa352-d98a-4e96-b80b-a66c07e19e50 61 fields · synced May 18, 2026
- EUDAMED 7290a28b-ebda-41d6-b99a-eb4fc5e1429b 61 fields · synced Jul 8, 2026