YSI Incorporated

Basic Information

• Brand Name: YSI Incorporated
• Primary DI: 00851683007158
• Version / Model: 1515
• Catalog Number: 015098
• Company Name: YSI INCORPORATED
• Labeler DUNS: 004246716
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-31
• Public Version: 5
• Public Version Date: 2022-10-10
• Public Version Status: Update
• Public Device Record Key: 59053938-25bc-4ae5-bca7-13ccc40e674e

Device Description

1515 CELL LYSING AGENT

Device Characteristics

• Single Use: Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	862.1345	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52735	Cell preservation/storage/dilution solution IVD	A solution intended to be used for the preservation, storage, washing, dilution and/or resuspension of cells (e.g., red and/or white blood cells, epithelial, bacterial, fungal, etc.) in a clinical specimen or a cell isolate, to maintain cell stability and/or facilitate further in vitro diagnostic testing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851683007158	GS1