Identity
- Trade Name
- NOVA Lite® IFA Yo (PCA-1) Positive Control EUDAMED
- Device Name
- NOVA Lite® IFA Yo (PCA-1) Positive Control EUDAMED
- Model / Reference
- 704009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00195126001045 EUDAMED
- Basic UDI-DI
- 84269505942609N EUDAMED
- EMDN Code
- W0102152011 CONTROLS FOR AUTOIMMUNITY EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
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
NOVA Lite® IFA Yo (PCA-1) Positive Control by Inova Diagnostics, Inc. — Class B — 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 | 84269505942609N | Class B | Active |
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Manufacturer
- Manufacturer
- Inova Diagnostics. Inc.
- EUDAMED SRN
- US-MF-000017851
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 888bdc98-fc13-4451-a351-15376a8de2b7 61 fields · synced Jul 11, 2026