Identity
- Trade Name
- VivaScope 2500 FDA UDI
- Generic Name
- Scanning laser optical microscope FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 2500 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08602920003035 FDA UDI
- FDA Product Code
- IBK FDA UDI
- GMDN Term
- Scanning laser optical microscope FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3600 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Scanning laser optical microscope
VivaScope 2500 by Caliber Imaging & Diagnostics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- VivaScope System — Caliber Imaging & Diagnostics, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Caliber Imaging & Diagnostics, Inc.
Sources (1)
- FDA UDI 1e9f3903-f555-43b1-b6ab-b734cfe85387 34 fields · synced Jun 9, 2026