CINtec® p16 Histology 06695221001

GUDID 04015630970445

Ventana Medical Systems, Inc.

p16 antigen IVD, antibody p16 antigen IVD, antibody p16 antigen IVD, antibody p16 antigen IVD, antibody

• Primary Device ID: 04015630970445
• NIH Device Record Key: a25bc817-6b7f-4afe-ae84-434de18f2475
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CINtec® p16 Histology
• Version Model Number: 06695221001
• Catalog Number: 06695221001
• 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	04015630970445 [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: 2022-12-15
• Device Publish Date: 2022-12-07

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