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NOVA View® Automated Fluorescence Microscope
EUDAMEDFDA UDIClass A (EU MDR)
Ref NV2000
Identity
- Trade Name
- NOVA View® Automated Fluorescence Microscope EUDAMEDFDA UDI
- Generic Name
- Cell morphology analyser IVD, automated/semi-automated FDA UDI
- Device Name
- NOVA View® Automated Fluorescence Microscope EUDAMEDNOVA View® Automated Fluorescent Microscope is an automated system consisting of a fluorescence microscope and software that acquires, analyzes, stores and displays digital images of stained indirect immunofluorescent slides. Optional AutoLoader available as an accessory. FDA UDI
- Model / Reference
- NV2000 EUDAMEDFDA UDI
- Description
- NOVA View® Automated Fluorescent Microscope is an automated system consisting of a fluorescence microscope and software that acquires, analyzes, stores and displays digital images of stained indirect immunofluorescent slides. Optional AutoLoader available as an accessory. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08426950621614 EUDAMEDFDA UDI
- Basic UDI-DI
- 84269506216147E EUDAMED
- FDA Product Code
- PIV FDA UDI
- EMDN Code
- W0201020104 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HIGH ROUTINE (Throughput > 700 test/h) EUDAMED
- GMDN Term
- Cell morphology analyser IVD, automated/semi-automated FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 866.4750 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
NOVA View® Automated Fluorescence Microscope by Inova Diagnostics, Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 84269506216147E | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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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 (2)
- EUDAMED aab0929f-c199-4791-ad8c-09ff87799550 61 fields · synced Jun 8, 2026
- FDA UDI 3d35554d-f095-4e2d-80e7-ffe52a2fecb7 35 fields · synced May 30, 2026