VENTANA MET (SP44) RxDx Assay 08866856001

GUDID 07613336168974

Ventana Medical Systems, Inc.

Hepatocyte growth factor receptor (HGFR) IVD, antibody

• Primary Device ID: 07613336168974
• NIH Device Record Key: 73072f75-4604-4c23-a734-6fdb8973916c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VENTANA MET (SP44) RxDx Assay
• Version Model Number: 08866856001
• Catalog Number: 08866856001
• 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: true
• 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	07613336168974 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P240037

FDA Product Code

• SER: Immunohistochemistry Assay, Antibody, MET

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: 2025-06-30
• Device Publish Date: 2025-06-20

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