Hemolysis and Wash Solution

Basic Information

• Brand Name: Hemolysis and Wash Solution
• Primary DI: 00853931008030
• Version / Model: 018431US
• Company Name: TOSOH BIOSCIENCE, INC.
• Labeler DUNS: 607696440
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-23
• Public Version: 3
• Public Version Date: 2023-06-02
• Public Version Status: Update
• Public Device Record Key: 7ca72db7-ca96-42bc-9d73-f446bc3bb06a

Device Description

Red Cell Lysing Reagent

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
GGK	Products, Red-Cell Lysing Products	Hematology	864.8540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58236	Buffered wash solution IVD	A buffered wash solution intended to be used as a consumable reagent in combination with other IVDs during manual procedures or on-board an automated or semi-automated instrument for the processing, staining and/or testing of clinical laboratory specimens to neutralize/wash/rinse away excess reactants and/or to function as a wetting agent.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00853931008030	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]