NOVA View Automated Fluorescense Microscope
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- DEN140039 FDA 510(k)
- FDA Product Code
- PIV FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.4750 FDA 510(k)
- Regulation Number
- 866.4750 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- DENG FDA 510(k)
The Nova View Automated Fluorescence Microscope is an automated indirect immunofluorescence (IFA) microscope and software-assisted system designed for clinical use. It falls under the classification of an automated IFA microscope, enabling automated acquisition, analysis, and digital storage of IFA-stained slides. This system is intended for use in immunology applications, where precise and reproducible analysis of fluorescent staining patterns is critical. The device integrates imaging technology with automated slide handling to enhance diagnostic workflows in laboratory settings.
The Nova View Automated Fluorescence Microscope is supplied as a standalone system, including a fluorescence microscope and associated software for image processing. It is intended for single-use or reusable slide handling (with optional AutoLoader), though sterility specifications are not explicitly stated in the data. The device operates in clinical laboratory environments and complies with FDA 510(k) clearance and In Vitro Diagnostic Regulation (IVDR) requirements. It is classified under device class II (PIV) and is regulated under FDA regulation number 866.4750. No MRI safety information is provided.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Digital microscope - NOVA View® - Inova Diagnostics - laboratory ..., NOVA View IFA Microscope | Werfen North America, RevMed Marketplace | Connecting the Dots
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | DEN140039 | Class II | Active |
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Manufacturer
- Manufacturer
- Inova Diagnostics, Inc.
Sources (2)
- FDA 510(k) DEN140039 24 fields · synced Sep 20, 2026
- EUDAMED 1 fields · synced May 19, 2026