CINtec® p16 Histology 06695221001

GUDID 04015630970445

Ventana Medical Systems, Inc.

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

Devices Manufactured by Ventana Medical Systems, Inc.

• 07613336149201 - VENTANA CLDN18 (43-14A) RxDx Assay: 2024-12-19
• 07613336223512 - anti-p40 (SP225) Rabbit Monoclonal Primary Antibody: 2024-05-29
• 07613336221099 - VENTANA FGFR2b (FPR2-D) Mouse Monoclonal Antibody: 2024-02-07
• 07613336219898 - anti-CD8 (SP239) Rabbit Monoclonal Primary Antibody: 2023-07-07
• 04015630967087 - CONFIRM anti-S100 (Polyclonal) Primary Antibody: 2022-12-15
• 04015630970063 - CONFIRM anti-ALK1 (ALK01) Primary Antibody: 2022-12-15
• 04015630970445 - CINtec® p16 Histology: 2022-12-15
• 04015630970445 - CINtec® p16 Histology: 2022-12-15
• 04015630971015 - Anti-p53 (Bp53-11) Primary Antibody: 2022-12-15