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Influenza A+B Ag Control Solution (FIA)
EUDAMEDClass IVD General (EU MDR)
Ref VIC36-08-011Model VIC36
Identity
- Trade Name
- Influenza A+B Ag Control Solution (FIA) EUDAMEDInfluenza A+B Ag Control EUDAMED
- Device Name
- Influenza A+B Ag Control EUDAMED
- Model / Reference
- VIC36 EUDAMEDVIC36-08-011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-VIC362X EUDAMED06937339210432 EUDAMED
- Basic UDI-DI
- B-VIC362X EUDAMEDB-06937339210432 EUDAMED
- EMDN Code
- W0102152099 CONTROLS- IMMUNOCHEMISTRY - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Influenza A+B Ag Control Solution (FIA) by VivaChek Biotech (Hangzhou) Co., Ltd. — 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-VIC362X | Class IVD General | Active |
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Manufacturer
- Manufacturer
- VivaChek Biotech (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000012160
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 78946a7e-bb61-46cc-9aa5-5027674c8ebe 61 fields · synced Oct 6, 2026
- EUDAMED 71efb1f5-9f28-4fd0-beb4-609f0d01a066 61 fields · synced Jul 10, 2026