Identity
- Trade Name
- AAV5 NAb Test Specimen Collection Kit EUDAMED
- Device Name
- AAV5 NAb Test Specimen Collection Kit EUDAMED
- Model / Reference
- GTKIT80001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00860006973513 EUDAMED
- Basic UDI-DI
- 0860006973517L EUDAMED
- EMDN Code
- W050101010201 BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
AAV5 NAb Test Specimen Collection Kit by Precision for Medicine, Inc. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 0860006973517L | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Precision for Medicine, Inc.
- EUDAMED SRN
- US-MF-000007346
- Authorised Representative
- QbD RepS BV BE-AR-000000040
Sources (1)
- EUDAMED 8cd4ef66-83e6-4afa-bb91-df136af38bd0 61 fields · synced Jul 17, 2026