High-AR

Basic Information

• Brand Name: High-AR
• Primary DI: 08435804515061
• Version / Model: MAD-004075VSBC
• Company Name: VITRO SA
• Labeler DUNS: 466076718
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-20
• Public Version: 1
• Public Version Date: 2025-02-28
• Public Version Status: New
• Public Device Record Key: 5f1a0b5f-7362-4571-a340-710845bad15c

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• 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
PPM	General Purpose Reagent	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57770	Immunohistochemistry antigen retrieval reagent IVD	A substance or reactant intended to be used for the non-enzymatic retrieval of antigenic epitopes from biological tissues or clinical specimen, using an enzyme immunohistochemistry assay.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08435804515061	GS1