DxH C67249

GUDID 15099590744830

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.

Beckman Coulter, Inc.

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• Primary Device ID: 15099590744830
• NIH Device Record Key: a62c1d8d-ed0b-441b-a4fc-8965d04632ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DxH
• Version Model Number: C67249
• Catalog Number: C67249
• Company DUNS: 008254708
• Company Name: Beckman Coulter, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	15099590744830 [Primary]

FDA Product Code

• GIF: Diluent, Blood Cell

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-14
• Device Publish Date: 2023-08-04

On-Brand Devices [DxH]

• 15099590744830: DxH Concentrated ECO Diluent, when diluted to a working concentration, is an osmotically balance
• 15099590744847: DxH ECO Diluent is an osmotically balanced, pH neutral solution of organic buffers, germicides,
• 15099590744854: DxH ECO Cell Lyse is a cyanide-free reagent that measures hemoglobin by the oxyhemoglobin method