VENTANA Red ISH DIG Detection Kit 08318832001

GUDID 07613336158357

Ventana Medical Systems, Inc.

Nucleic acid hybridization detection IVD, kit

• Primary Device ID: 07613336158357
• NIH Device Record Key: c068ef17-8d7a-415f-8562-818018501bfe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VENTANA Red ISH DIG Detection Kit
• Version Model Number: 08318832001
• Catalog Number: 08318832001
• Company DUNS: 184042521
• Company Name: Ventana Medical Systems, 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: true
• 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	07613336158357 [Primary]

FDA Product Code

• NJT: IMMUNOHISTOCHEMISTRY REAGENTS AND KITS

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: 2025-12-23
• Device Publish Date: 2025-12-15

Devices Manufactured by Ventana Medical Systems, Inc.

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• 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