VENTANA FOLR1 (FOLR1-2.1) RxDx Assay

Basic Information

• Brand Name: VENTANA FOLR1 (FOLR1-2.1) RxDx Assay
• Primary DI: 07613336103241
• Version / Model: 07727917001
• Catalog Number: 07727917001
• Company Name: Ventana Medical Systems, Inc.
• Labeler DUNS: 184042521
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-01
• Public Version: 1
• Public Version Date: 2022-12-09
• Public Version Status: New
• Public Device Record Key: db3020ae-e09b-476e-afa8-3cfcdf64b555

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
QUL	Immunohistochemistry Assay, Antibody, FOLR1	Hematology	864.1860	3

GMDN Terms

Code	Name	Definition	Implantable	Status
62801	Folate receptor alpha (FRa) 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 folate receptor alpha (FRa), in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613336103241	GS1

Premarket Submissions

Submission Number	Supplement Number
P220006	000