VENTANA HER2 Dual ISH DNA Probe Cocktail 08314365001

GUDID 07613336158432

Ventana Medical Systems, Inc.

Nucleic acid hybridization detection IVD, probe

• Primary Device ID: 07613336158432
• NIH Device Record Key: 877db5c3-c2a6-483b-8fbd-4af78b3f1e78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VENTANA HER2 Dual ISH DNA Probe Cocktail
• Version Model Number: 08314365001
• Catalog Number: 08314365001
• Company DUNS: 184042521
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613336158432 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P190031

FDA Product Code

• NYQ: Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer

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: 2021-04-19
• Device Publish Date: 2021-04-09

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