CINtec p16 Histology (50) CE 06695248001

GUDID 04015630984299

Ventana Medical Systems, Inc.

p16 antigen IVD, antibody

• Primary Device ID: 04015630984299
• NIH Device Record Key: 84e012a4-938c-4ee0-90aa-a7dd39719cf7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CINtec p16 Histology (50) CE
• Version Model Number: 06695248001
• Catalog Number: 06695248001
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04015630984299 [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: 2025-07-15
• Device Publish Date: 2025-07-07

Devices Manufactured by Ventana Medical Systems, Inc.

• 04015630971114 - LCS (Predilute): 2025-07-15
• 04015630976867 - ASSY,Reag.Disp.Card,PrepKit 18,BenchMark: 2025-07-15
• 04015630984299 - CINtec p16 Histology (50) CE: 2025-07-15
• 04015630984299 - CINtec p16 Histology (50) CE: 2025-07-15
• 07613336100981 - ASSY,Reag.Disp.Card,PrepKit 13,BenchMark: 2025-07-15
• 07613336100998 - ASSY,Reag.Disp.Card,PrepKit 14,BenchMark: 2025-07-15
• 07613336101001 - ASSY,Reag.Disp.Card,PrepKit 4,BenchMark: 2025-07-15
• 07613336101018 - ASSY,Reag.Disp.Card,PrepKit 100,BenchMar: 2025-07-15
• 07613336101179 - NexES Dispenser Card Counterstain 1: 2025-07-15