Access CEA Calibrators 33205

GUDID 15099590624835

The Access CEA Calibrators (BSA matrix) are intended to calibrate the Access CEA assay for the quantitative determination of Carcinoembryonic Antigen

Beckman Coulter, Inc.

Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 15099590624835
• NIH Device Record Key: 0f22491a-b49d-4020-9cac-20181c3f2a97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access CEA Calibrators
• Version Model Number: 33205
• Catalog Number: 33205
• 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	15099590624835 [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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