DxC AU

GUDID 14987666542491

DxC 700 AU Chemistry Analyzer

Beckman Coulter, Inc.

Multiple clinical chemistry analyser IVD, laboratory, automated

• Primary Device ID: 14987666542491
• NIH Device Record Key: 082aac47-26b1-4679-9999-a5e86aa85b0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DxC AU
• Version Model Number: B86443
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	14987666542491 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161837

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: 2020-09-01
• Device Publish Date: 2020-08-24

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• 14987666545058: DxC 500 AU Clinical Chemistry Analyzer