DxA 5000

GUDID 15099590707118

DxA 5000

Beckman Coulter, Inc.

Specimen processing instrument IVD, automated

• Primary Device ID: 15099590707118
• NIH Device Record Key: 1018fb63-2c68-4fdb-9a84-4bba2fc15a61
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DxA 5000
• Version Model Number: DxA 5000
• Company DUNS: 008254708
• Company Name: Beckman Coulter, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Serial Number: true
• 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

Customer Support Contacts

• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com
• Phone: (800) 854-3633
• Email: xx@xx.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 16 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15099590707118 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190298

FDA Product Code

• JJE: Analyzer, Chemistry (Photometric, Discrete), For Clinical 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: 2019-11-12
• Device Publish Date: 2019-11-04

Devices Manufactured by Beckman Coulter, Inc.

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• 15099590763640 - Access Syphilis QC: 2025-05-15 The Access Syphilis QC is intended for monitoring system performance of the Access Syphilis assay. The Access Syphilis QC is for
• 05099590798218 - DxH: 2025-04-14 Beckman Coulter DxH Slides are 25 x 75 x 1 mm glass microscope slides with white or painted frosted ends, used with the DxH Slid
• 14987666545072 - DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module: 2025-04-08 The DxC 500i Clinical Analyzer combines the DxC 500 AU Clinical Chemistry Analyzer and the Access 2 Immunoassay System into a si
• 14987666545089 - DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module: 2025-04-08 The DxC 500i Clinical Analyzer combines the DxC 500 AU Clinical Chemistry Analyzer and the Access 2 Immunoassay System into a si
• 15099590742331 - DxC 500i Clinical Analyzer, DxC 500i Access 2 Immunoassay Module: 2025-04-08 The DxC 500i Clinical Analyzer combines the DxC 500 AU Clinical Chemistry Analyzer and the Access 2 Immunoassay System into a si
• 15099590209636 - DxH: 2024-11-19 Beckman Coulter DxH Slides are microscopic slides intended to be used to prepare whole blood samples for histological stains and