HER2 Dual ISH 3-in-1 Xenograft Slides 05640300001

GUDID 04015630972524

Ventana Medical Systems, Inc.

CD79a cell marker IVD, antibody CD79a cell marker IVD, antibody CD79a cell marker IVD, antibody CD79a cell marker IVD, antibody CD79a cell marker IVD, antibody CD79a cell marker IVD, antibody CD79a cell marker IVD, antibody CD79a cell marker IVD, antibody CD79a cell marker IVD, antibody CD79a cell marker IVD, antibody CD79a cell marker IVD, antibody CD79a cell marker IVD, antibody CD79a cell marker IVD, antibody CD79a cell marker IVD, antibody CD79a cell marker IVD, antibody CD79a cell marker IVD, antibody Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control Nucleic acid hybridization detection IVD, control

• Primary Device ID: 04015630972524
• NIH Device Record Key: 3eeaecd1-ee13-44bd-9d7d-b2c53a6d8bdf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HER2 Dual ISH 3-in-1 Xenograft Slides
• Version Model Number: 05640300001
• Catalog Number: 05640300001
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04015630972524 [Primary]

FDA Product Code

• KIR: CELLS, ANIMAL AND HUMAN, CULTURED

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: 2021-02-11
• Device Publish Date: 2021-02-03

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