PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody 05278368001

GUDID 04015630972197

Ventana Medical Systems, Inc.

Human epidermal growth factor receptor 2 (HER2) protein IVD, antibody

• Primary Device ID: 04015630972197
• NIH Device Record Key: 657e2a8a-347c-4aa6-94d8-00793e2568e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody
• Version Model Number: 50 tests
• Catalog Number: 05278368001
• 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	04015630972197 [Primary]

FDA Product Code

• MVC: SYSTEM, TEST, HER-2/NEU, IHC

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: 2025-09-08
• Device Publish Date: 2014-09-11

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