DxH Concentrated ECO Diluent, when diluted to a working concentration, is an osmotically balanced, pH neutral solution of organic buffers, germicides, and sodium/potassium salts. The diluent acts as an electrolyte and cell volume stabilizer for the automated quantitative analysis of red blood cells, platelets, and with the addition of DxH ECO Lytic reagent, the differentiation of leukocytes subpopulations, and hemoglobin measurement.
DxH - C67249
Device Description
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 one or multiple whole blood cell parameters in a clinical specimen [also known as complete blood count (CBC)]. Test components may include white cell count and differential, haemoglobin determination, red cell count, red cell characterization and calculation of red cell parameters, and/or platelet count.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
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: 15099590744830
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