Access CEA 33200

GUDID 15099590624842

The Access CEA assay is a paramagnentic particle, chemiluminescent immunoassay for the quantitative determination of Carcinoembryonic Antigen (CEA) le

Beckman Coulter, Inc.

Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 15099590624842
• NIH Device Record Key: 78de0139-ece0-4e59-a358-cf22fba08207
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access CEA
• Version Model Number: 33200
• Catalog Number: 33200
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	15099590624842 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031270

FDA Product Code

• DHX: System, Test, Carcinoembryonic Antigen

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-09

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