CINtec Histology

Basic Information

• Brand Name: CINtec Histology
• Primary DI: 04015630970476
• Version / Model: 06680011001
• Catalog Number: 06680011001
• Company Name: Ventana Medical Systems, Inc.
• Labeler DUNS: 184042521
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-21
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 6e036554-fc2b-48ed-8a8a-01c6e393987b

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PRB	Cervical intraepithelial neoplasia (CIN) test system	Pathology	864.1865	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57495	p16 antigen IVD, antibody	One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of p16 antigen in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04015630970476	GS1

Premarket Submissions

Submission Number	Supplement Number
DEN160019	000