DIAMINOBENZIDINE

Basic Information

• Brand Name: DIAMINOBENZIDINE
• Primary DI: 04061834202240
• Version / Model: 3911-1VL
• Company Name: Sigma-Aldrich, Inc.
• Labeler DUNS: 832563121
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-21
• Public Version: 2
• Public Version Date: 2022-05-11
• Public Version Status: Update
• Public Device Record Key: 2d1aec26-bcf9-4c5d-90b0-f3153827757d

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
GIA	Test, Leukocyte Peroxidase	Hematology	864.7675	1

GMDN Terms

Code	Name	Definition	Implantable	Status
53131	Myeloperoxidase (MPO) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of the enzyme myeloperoxidase (MPO) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04061834202240	GS1

Storage Conditions

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