Question 1

What types of medical devices does Bio-View Ltd manufacture?

Accepted Answer

Bio-View Ltd specializes in fluorescence light microscopes, specifically designed for biological imaging. These devices are tailored to enhance the visualization of fluorescently labeled samples, which is critical in research and clinical settings like cell biology and pathology. The focus is on improving precision and clarity in imaging applications.

Question 2

Where is Bio-View Ltd based?

Accepted Answer

Bio-View Ltd is headquartered in the United States. The company’s location ensures it operates within the regulatory framework of the FDA, which governs the classification and listing of its medical devices.

Question 3

Which regulatory registries list Bio-View Ltd’s devices?

Accepted Answer

Bio-View Ltd’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices authorized for use in the United States, ensuring transparency and traceability in the supply chain.

Question 4

How are Bio-View Ltd’s devices classified under FDA regulations?

Accepted Answer

Bio-View Ltd’s fluorescence light microscopes fall under Class II classification according to FDA regulations. This classification is determined based on the device’s intended use and potential risk level, requiring specific controls to ensure safety and effectiveness without needing the stringent pre-market approval process of Class III devices.

Device	Model / Reference	Registries	Class	Status
Duet™	Solo Terminal Server	FDA UDI	Class II	Active
Duet™	Encore 100 Slide Loader	FDA UDI	Class II	Active
Duet™	Solo Software	FDA UDI	Class II	Active
Duet™	SOLO WEB 10 User License	FDA UDI	Class II	Active
Duet™	Duet-3	FDA UDI	Class II	Active
Duet™	Solo Workstation	FDA UDI	Class II	Active
Duet™	Amniotic Cells Application	FDA UDI	Class II	Active
Duet™	HER2/NEU Application	FDA UDI	Class II	Active
Duet™	Encore 200 Slide Loader	FDA UDI	Class II	Active
Duet™	Solo Workstation w/ Touch Screen	FDA UDI	Class II	Active
Duet™	Hematological Application	FDA UDI	Class II	Active
Duet™	Automated Brightfield Scanning Application	FDA UDI	Class II	Active
Duet™	Tissue Setup Microscope Workstation	FDA UDI	Class II	Active
Duet™	Cell Suspension Target FISH Application	FDA UDI	Class II	Active
Duet™	Long Life Fluorescent Lamp	FDA UDI	Class II	Active
Duet™	Tissue Matching Application	FDA UDI	Class II	Active
Duet™	Bladder Application	FDA UDI	Class II	Active
Duet™	Accord	FDA UDI	Class II	Active
Duet™	AneuVysion Application	FDA UDI	Class II	Active
Duet™	ALK Application	FDA UDI	Class II	Active
Duet™	Accord Plus	FDA UDI	Class II	Active
Duet™	Allegro-Plus	FDA UDI	Class II	Active

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