VENTANA PD-L1 (SP263) Assay 07208162001

GUDID 04015630972784

Ventana Medical Systems, Inc.

Programmed death-ligand 1 (PD-L1) IVD, antibody

• Primary Device ID: 04015630972784
• NIH Device Record Key: dd70dc67-19c7-4989-a5b8-1606a046d44a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VENTANA PD-L1 (SP263) Assay
• Version Model Number: 50 test
• Catalog Number: 07208162001
• 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: true
• 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	04015630972784 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P160046

FDA Product Code

• PLS: Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-11-08
• Device Publish Date: 2017-09-26

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