STROMATOLYSER-4DS

Basic Information

• Brand Name: STROMATOLYSER-4DS
• Primary DI: 10664369201385
• Version / Model: FFS-800A
• Company Name: SYSMEX CORPORATION
• Labeler DUNS: 690664461
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2022-11-04
• Public Version: 1
• Public Version Date: 2022-11-14
• Public Version Status: New
• Public Device Record Key: 8557963b-392f-45ee-a4d9-96effe23b23f

Device Description

Stain reagent for hematology analyzers

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
KQC	Stains, Hematology	Hematology	864.1850	1

GMDN Terms

Code	Name	Definition	Implantable	Status
55859	White blood cell count 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 the white blood cell (leukocyte) count and/or the differential of white cell types in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	80664369201384	GS1
Primary	10664369201385	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Total Volume	42	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: DO NOT FREEZE
• Type: Storage Environment Temperature
• Temperature Range: 2 – 35 Degrees Celsius