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nAbCyte Anti-AAVRh74var HB-FE Assay
EUDAMEDClass IVD General (EU MDR)
Ref Anti-Spark 100 nAb AssayModel nAbCyte Anti-AAVRh74var HB-FE Assay 81-Test Device Kit
Identity
- Trade Name
- nAbCyte Anti-AAVRh74var HB-FE Assay EUDAMED
- Device Name
- nAbCyte Anti-AAVRh74var HB-FE Assay EUDAMED
- Model / Reference
- nAbCyte Anti-AAVRh74var HB-FE Assay 81-Test Device Kit EUDAMEDAnti-Spark 100 nAb Assay EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-AntiSpark100nAbAssay8B EUDAMED
- Basic UDI-DI
- B-AntiSpark100nAbAssay8B EUDAMED
- EMDN Code
- W0102010199 IMMUNOGLOBULINS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
Yes
EUDAMED
Surgical Instrument
No
EUDAMED
nAbCyte Anti-AAVRh74var HB-FE Assay by Laboratory Corporation of America Holdings — 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-AntiSpark100nAbAssay8B | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Laboratory Corporation of America Holdings
- EUDAMED SRN
- US-MF-000017722
- Authorised Representative
- European Healthcare & Device Solutions Ltd. IE-AR-000003999
Sources (1)
- EUDAMED c3d7de02-0c84-4eaf-96c2-3c81161703cf 61 fields · synced Oct 6, 2026