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ChainFor Vesicular Rash Genotyping Detection qPCR Kit
EUDAMEDClass IVD General (EU MDR)
Ref CFP89Ref PCR61Model CFP61P100
Identity
- Trade Name
- ChainFor Vesicular Rash Genotyping Detection qPCR Kit EUDAMEDChainFor™ EUDAMED
- Device Name
- Vesicular Rash Genotyping Detection qPCR Kit EUDAMEDHSV-1/HSV-2/VZV Genotyping qPCR Kit EUDAMED
- Model / Reference
- CFP89 EUDAMEDCFP61P100 EUDAMEDPCR61 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08683548257864 EUDAMED
- Basic UDI-DI
- B-08683548257864 EUDAMED
- EMDN Code
- W0105040311,W0105040904 EUDAMEDW0105070302 OTHER VIRUS COMBINATIONS - MULTIPLEX NA REAGENTS EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Germany EUDAMEDTürkiye 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
EUDAMEDEUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
Yes
EUDAMEDEUDAMED
Surgical Instrument
Yes
EUDAMEDEUDAMED
ChainFor Vesicular Rash Genotyping Detection qPCR Kit by Vitrosens Biotechnology Inc. — Class IVD General — 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-08683548257864 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Vitrosens Biotechnology Inc.
- EUDAMED SRN
- TR-MF-000026452
Sources (2)
- EUDAMED 19f6f825-4c3f-4fac-a5e1-64b39a02179a 61 fields · synced Oct 10, 2026
- EUDAMED 15be741c-8779-408a-a138-c4fb11eb731f 61 fields · synced Oct 10, 2026