DxH ECO Diluent 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.


Product Overview

DxH ECO Diluent 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 - C67250


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 Identifiers

Device Id: 15099590744847

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


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