CINtec PLUS Cytology

Basic Information

• Brand Name: CINtec PLUS Cytology
• Primary DI: 04015630977215
• Version / Model: 100 test
• Catalog Number: 07478496001
• Company Name: Ventana Medical Systems, Inc.
• Labeler DUNS: 184042521
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-10
• Public Version: 2
• Public Version Date: 2021-08-13
• Public Version Status: Update
• Public Device Record Key: 20aeac07-2b3c-409e-836a-ea5b639d7a27

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
57337	Ki67 antigen IVD, kit, enzyme immunohistochemistry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of Ki67 antigen in a clinical specimen, using an enzyme immunohistochemistry method.	No	Active
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	04015630977215	GS1

Premarket Submissions

Submission Number	Supplement Number
P190024	000