CONFIRM anti-ALK1 (ALK01) Primary Antibody 05278783001

GUDID 04015630972128

Ventana Medical Systems, Inc.

Anaplastic lymphoma kinase IVD, antibody

• Primary Device ID: 04015630972128
• NIH Device Record Key: 4c096bb8-8164-41d1-8f87-6a44b99e47fb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONFIRM anti-ALK1 (ALK01) Primary Antibody
• Version Model Number: 05278783001
• Catalog Number: 05278783001
• 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: 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	04015630972128 [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

On-Brand Devices [CONFIRM anti-ALK1 (ALK01) Primary Antibody]

• 04015630970063: 05278147001
• 04015630972128: 05278783001