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LyoSens MTB/non-TB Genotyping qPCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref LYO82Model LYO82WS96
Identity
- Trade Name
- LyoSens MTB/non-TB Genotyping qPCR Kit EUDAMED
- Device Name
- MTB/non-TB Genotyping qPCR Kit EUDAMED
- Model / Reference
- LYO82WS96 EUDAMEDLYO82 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08685115803450 EUDAMED
- Basic UDI-DI
- B-08685115803450 EUDAMED
- EMDN Code
- W0105010703 MYCOBACTERIAL 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
Yes
EUDAMED
Surgical Instrument
Yes
EUDAMED
LyoSens MTB/non-TB Genotyping 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-08685115803450 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Vitrosens Biotechnology Inc.
- EUDAMED SRN
- TR-MF-000026452
Sources (1)
- EUDAMED 2ff77c6f-1356-4fe6-a8de-4bb810d82ec0 61 fields · synced Jun 19, 2026