CINtec PLUS Cytology 07478496001

GUDID 04015630977215

Ventana Medical Systems, Inc.

Ki67 antigen IVD, kit, enzyme immunohistochemistry Ki67 antigen IVD, kit, enzyme immunohistochemistry Ki67 antigen IVD, kit, enzyme immunohistochemistry Ki67 antigen IVD, kit, enzyme immunohistochemistry Ki67 antigen IVD, kit, enzyme immunohistochemistry Ki67 antigen IVD, kit, enzyme immunohistochemistry Ki67 antigen IVD, kit, enzyme immunohistochemistry Ki67 antigen IVD, kit, enzyme immunohistochemistry Ki67 antigen IVD, kit, enzyme immunohistochemistry Ki67 antigen IVD, kit, enzyme immunohistochemistry

• Primary Device ID: 04015630977215
• NIH Device Record Key: 20aeac07-2b3c-409e-836a-ea5b639d7a27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CINtec PLUS Cytology
• Version Model Number: 100 test
• Catalog Number: 07478496001
• 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: true
• Device Combination Product: false
• Single Use: true
• 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	04015630977215 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P190024

FDA Product Code

• QKF: Immunocytochemistry assay, p16/Ki-67

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: 2020-04-20
• Device Publish Date: 2020-04-10

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