Lysercell WDF is a reagent product to be combined and used with Fluorocell WDF. By hemolyzing red blood cells with Lysercell WDF and dyeing the white blood cell component with Fluorocell WDF, the counts and percentages of neutrophils, lymphocytes, monocytes, and eosinophils are analyzed. This reagent is to be used by connecting to an automatic hematology analyzer specified by Sysmex.
LYSERCELL WDF - AW993605
Device Description
A substance or reactant intended to be used alone or in combination with other IVDs to disrupt the cell membrane of blood cells [red blood cells (RBCs), white blood cells (WBCs) and/or platelets] to release cytoplasmic contents in preparation for further analysis.
Environmental Conditions
- 35.00
- 2.00
Device Sizes
- Total Volume: 4 Liter
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: GGK
Device Name: Products, Red-Cell Lysing Products
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: HE
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 864.8540
Third Party Flag: N
Medical Specialty: HE
Device IdentifiersDevice Id: 14987562422996
Device Type: Unit of Use
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
Device Id: 04987562422999
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A