Cytomics FC500 626553

GUDID 15099590572839

Cytomics FC 500 with CXP Software

Beckman Coulter, Inc.

Flow cytometry analyser IVD, semi-automated

• Primary Device ID: 15099590572839
• NIH Device Record Key: efcea942-49d1-4525-89ee-583d58616123
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cytomics FC500
• Version Model Number: UPS (CXP)
• Catalog Number: 626553
• 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	15099590572839 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030828

FDA Product Code

• GKZ: Counter, Differential Cell

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [Cytomics FC500]

• 15099590572839: Cytomics FC 500 with CXP Software
• 15099590572822: Cytomics FC 500 MPL with MXP Software