DxH B01276

GUDID 15099590209636

Beckman Coulter DxH Slides are microscopic slides intended to be used to prepare whole blood samples for histological stains and preservation of blood for microscopic evaluation. Beckman Coulter DxH Slides are 25 x 75 x 1 mm glass microscope slides with white or painted frosted ends. Beckman Coulter DxH Slides are used with the DxH Slidemaker Stainers, fully automated slide preparation and staining devices that smear a blood film on a clean microscope slide, and deliver a variety of fixatives, stains, buffers, and rinse solutions to the blood smear on the slide.

Beckman Coulter, Inc.

General specimen microscopy slide IVD, single-use

• Primary Device ID: 15099590209636
• NIH Device Record Key: e528114f-02fd-4385-983f-978e1ed77669
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DxH
• Version Model Number: B01276
• Catalog Number: B01276
• Company DUNS: 008254708
• Company Name: Beckman Coulter, Inc.
• Device Count: 20
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	05099590209639 [Unit of Use]
GS1	15099590209636 [Primary]

FDA Product Code

• LXG: Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

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: 2024-11-19
• Device Publish Date: 2024-11-11

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
• 15099590209636: Beckman Coulter DxH Slides are microscopic slides intended to be used to prepare whole blood sam