VENTANA HER2 Dual ISH DNA Probe Cocktail 08314365001

GUDID 07613336158432

Ventana Medical Systems, Inc.

Nucleic acid hybridization detection IVD, probe Nucleic acid hybridization detection IVD, probe Nucleic acid hybridization detection IVD, probe Nucleic acid hybridization detection IVD, probe Nucleic acid hybridization detection IVD, probe Nucleic acid hybridization detection IVD, probe Nucleic acid hybridization detection IVD, probe Nucleic acid hybridization detection IVD, probe Nucleic acid hybridization detection IVD, probe Nucleic acid hybridization detection IVD, probe Nucleic acid hybridization detection IVD, probe Nucleic acid hybridization detection IVD, probe Nucleic acid hybridization detection IVD, probe Nucleic acid hybridization detection IVD, probe Nucleic acid hybridization detection IVD, probe

• Primary Device ID: 07613336158432
• NIH Device Record Key: 877db5c3-c2a6-483b-8fbd-4af78b3f1e78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VENTANA HER2 Dual ISH DNA Probe Cocktail
• Version Model Number: 08314365001
• Catalog Number: 08314365001
• 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	07613336158432 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P190031

FDA Product Code

• NYQ: Chromogenic in situ hybridization, nucleic acid amplification, HER2/NEU gene, breast cancer

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: 2021-04-19
• Device Publish Date: 2021-04-09

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