VivaScope 2500

GUDID 08602920003035

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.

Caliber Imaging & Diagnostics, Inc.

Scanning laser optical microscope

• Primary Device ID: 08602920003035
• NIH Device Record Key: 1e9f3903-f555-43b1-b6ab-b734cfe85387
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VivaScope 2500
• Version Model Number: 2500
• Company DUNS: 795857648
• Company Name: Caliber Imaging & Diagnostics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08602920003035 [Primary]

FDA Product Code

• IBK: Microscope, Fluorescence/U.V.

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-24
• Device Publish Date: 2023-02-16

Devices Manufactured by Caliber Imaging & Diagnostics, Inc.

• 08602920003035 - VivaScope 2500: 2023-02-24The 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.
• 08602920003035 - VivaScope 2500: 2023-02-24 The VivaScope 2500 is an IVD confocal microscope that produces enlarged images of fresh or fixed specimens, in reflectance (phas
• 08602920003066 - VivaScope System: 2023-02-24 The VivaScope® System is a reflectance confocal microscope, full color macroscopic imager, and software that captures images of
• 00860292000306 - VivaScope System: 2019-03-25 The VivaScope® System is a reflectance confocal microscope, full color macroscopic imager, and software that captures images of