The VivaScope 2500 is an IVD confocal microscope that produces enlarged images of fresh or fixed specimens, in reflectance (phase contrast) mode, or in fluorescence mode for specimens that…
The VivaScope 2500 is an IVD confocal microscope that produces enlarged images of fresh or fixed specimens, in reflectance (phase contrast) mode, or in fluorescence mode for specimens that are stained with fluorochromes that fluoresce when illuminated with a laser. The VivaScope 2500 is used by physicians and other licensed healthcare professionals to view enlarged images of specimens during pathological examinations.
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (1), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for VivaScope 2500 | Listed by | Caliber Imaging & Diagnostics, Inc., United States |
| FDA product code | IBK |
| Device type | Microscope, Fluorescence/U.V. |
| Device class | Class 1 |
| Regulation | 21 CFR 864.3600 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-02-16 |
| Record revised | 2025-02-05 (version 2) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Label carries | manufacturing date, serial number |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.