VIRTUOSO System for IHC

GUDID 04015630985043

VENTANA MEDICAL SYSTEMS, INC.

Histology/cytology image-analysis software IVD

• Primary Device ID: 04015630985043
• NIH Device Record Key: 77a41492-83c0-4262-80fa-6f8dfb4e6cfd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIRTUOSO System for IHC
• Version Model Number: v5
• Company DUNS: 078501720
• Company Name: VENTANA MEDICAL SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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	04015630985043 [Primary]

FDA Product Code

• NQN: Microscope,Automated,Image Analysis,Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-27
• Device Publish Date: 2016-09-24

Devices Manufactured by VENTANA MEDICAL SYSTEMS, INC.

• 04015630971008 - Antibody Diluent: 2025-12-23
• 04015630971176 - Bluing Reagent: 2025-12-23
• 04015630971299 - Amplification Kit: 2025-12-23
• 04015630971367 - Alcian Blue Staining Kit: 2025-12-23
• 04015630971374 - Alcian Blue for PAS: 2025-12-23
• 04015630971404 - Giemsa Staining Kit: 2025-12-23
• 04015630971411 - Iron Staining Kit: 2025-12-23
• 04015630971428 - Light Green for PAS: 2025-12-23