Endogenous Peroxidase Blocker

Basic Information

• Brand Name: Endogenous Peroxidase Blocker
• Primary DI: 00850042030073
• Version / Model: 1
• Company Name: Lumatas Biosystems, Inc.
• Labeler DUNS: 080169635
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-25
• Public Version: 1
• Public Version Date: 2023-11-02
• Public Version Status: New
• Public Device Record Key: 213723c7-5f46-4acb-ae3e-cfca585cba93

Device Description

Reagent that aids in the blocking of endogenous peroxidase activity within tissue samples

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NJT	Immunohistochemistry Reagents And Kits	Hematology	864.1860	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64517	Hydrogen peroxide (H2O2) IVD, kit, electrometry	An electrochemical electrode, reagents and other associated materials intended to be used for the quantitative measurement of hydrogen peroxide in a clinical specimen, using an electrometry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00850042030066	GS1		2	In Commercial Distribution
Primary	00850042030073	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius