VENTANA ALK D5F3 CDx Assay 06687199001

GUDID 04015630970094

Ventana Medical Systems, Inc.

Anaplastic lymphoma kinase IVD, antibody Anaplastic lymphoma kinase IVD, antibody Anaplastic lymphoma kinase IVD, antibody Anaplastic lymphoma kinase IVD, antibody Anaplastic lymphoma kinase IVD, antibody Anaplastic lymphoma kinase IVD, antibody Anaplastic lymphoma kinase IVD, antibody Anaplastic lymphoma kinase IVD, antibody Anaplastic lymphoma kinase IVD, antibody Anaplastic lymphoma kinase IVD, antibody Anaplastic lymphoma kinase IVD, antibody Anaplastic lymphoma kinase IVD, antibody Anaplastic lymphoma kinase IVD, antibody Anaplastic lymphoma kinase IVD, antibody Anaplastic lymphoma kinase IVD, antibody Anaplastic lymphoma kinase IVD, antibody

• Primary Device ID: 04015630970094
• NIH Device Record Key: e03d0e8b-33fd-467f-8a19-28dec11232e1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VENTANA ALK D5F3 CDx Assay
• Version Model Number: 50 tests
• Catalog Number: 06687199001
• 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	04015630970094 [Primary]

FDA Product Code

• PKW: Immunohistochemistry assay, antibody, anaplastic lymphoma kinase

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-10-06
• Device Publish Date: 2015-08-19

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