CELLSHEATH, in combination with the specified diluent, is a reagent for analyzing the numbers and sizes of RBC and platelets by the hydro dynamic focusing (DC Detection).
This reagent is to be used by connecting to an automatic hematology analyzer specified by Sysmex. Use as a sheath fluid for hematology analyzer.
CELLSHEATH - 05404811
Device Description
A buffered diluent solution intended to be used as a consumable reagent during manual procedures or on-board an automated or semi-automated instrument (e.g., haematological cell analyser) for the processing, staining and/or testing of clinical laboratory specimens (e.g., whole blood).
Environmental Conditions
- 30.00
- 1.00
Device Sizes
- Total Volume: 10 Liter
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: GIF
Device Name: Diluent, Blood Cell
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: 864.8200
Third Party Flag: N
Medical Specialty: HE
Device IdentifiersDevice Id: 04987562406005
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