DxH C67251

GUDID 15099590744854

DxH ECO Cell Lyse is a cyanide-free reagent that measures hemoglobin by the oxyhemoglobin method. Surfactants are used to lyse the erythrocytes and release the hemoglobin. The released oxyhemoglobin reacts with an antioxidant and a stabilizing reagent, converting the oxyhemoglobin into a stable hemochromogen, which is photometrically measured by the instrument. The lytic reagent also solubilizes the red blood cell membrane while simultaneously preserving the white blood cell and NRBC cellular morphology to be counted and sized.

Beckman Coulter, Inc.

Full blood count IVD, reagent

• Primary Device ID: 15099590744854
• NIH Device Record Key: b20fab43-a265-4d7a-b833-f34bf8a1bbda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DxH
• Version Model Number: C67251
• Catalog Number: C67251
• 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	15099590744854 [Primary]

FDA Product Code

• GGK: Products, Red-Cell Lysing Products

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: 2023-12-25
• Device Publish Date: 2023-12-15

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