SULFOLYSER

Basic Information

• Brand Name: SULFOLYSER
• Primary DI: 04987562422975
• Version / Model: BJ350971
• Company Name: SYSMEX CORPORATION
• Labeler DUNS: 690664461
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2022-11-30
• Public Version: 1
• Public Version Date: 2022-12-08
• Public Version Status: New
• Public Device Record Key: 05d2ab06-7085-421e-a985-be0b3460266f

Device Description

SULFOLYSER is a reagent for the automated determination of hemoglobin concentration of blood with Sysmex automated hematology analyzers.

Device Characteristics

• Single Use: No
• 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
55875	Total haemoglobin (totHb) 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 determination of total haemoglobin (totHb) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	84987562422971	GS1
Primary	04987562422975	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	1.5	Liter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 1 – 30 Degrees Celsius