VENTANA CLDN18 (43-14A) RxDx Assay 08287066001

GUDID 07613336149201

Ventana Medical Systems, Inc.

Claudin protein IVD, antibody

• Primary Device ID: 07613336149201
• NIH Device Record Key: 4baf60a2-6a65-4553-97f4-2533ad6f8191
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VENTANA CLDN18 (43-14A) RxDx Assay
• Version Model Number: 08287066001
• Catalog Number: 08287066001
• 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	07613336149201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P230018

FDA Product Code

• QJZ: Extracorporeal system for long-term respiratory / cardiopulmonary failure

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: 2024-12-19
• Device Publish Date: 2024-12-11

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