o-Dianisidine (Powder) (1 x 2 g)

Basic Information

• Brand Name: o-Dianisidine (Powder) (1 x 2 g)
• Primary DI: M52550360
• Version / Model: 5036
• Company Name: HELENA LABORATORIES CORPORATION
• Labeler DUNS: 079396131
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-17
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 251dac74-1f06-45df-b899-4dd669f826a2

Device Characteristics

• Single Use: Yes
• 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: 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
LEF	STAINS, DYE POWDER	Hematology	864.1850	1

GMDN Terms

Code	Name	Definition	Implantable	Status
53970	Protein electrophoresis 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 determining the qualitative and/or quantitative separation of proteins by electrophoresis, in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M52550360	HIBCC

Customer Contacts

• Phone: [phone] ext. 1600
• Email: [email protected]