Identity
- Trade Name
- AAV5 NAb Test EUDAMED
- Device Name
- AAV5 Neutralizing Antibody (NAb) Test EUDAMED
- Model / Reference
- C2201301EU EUDAMEDCC201301EU EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860006973537 EUDAMED
- Basic UDI-DI
- B-00860006973537 EUDAMED
- EMDN Code
- W01030199 HAEMATOLOGY REAGENTS - 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
No
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
AAV5 NAb Test by Precision for Medicine, 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-00860006973537 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Precision for Medicine, Inc.
- EUDAMED SRN
- US-MF-000007346
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED 0655cf51-75de-48f2-8ef5-db505abedf9b 61 fields · synced Jun 18, 2026