Access GI Monitor 387687

GUDID 15099590231842

The Access GI Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 19-9 antigen levels in h

Beckman Coulter, Inc.

Cancer antigen 19-9 (CA19-9) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 15099590231842
• NIH Device Record Key: f48f4909-9efd-454c-aa3a-7d307924cf7f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access GI Monitor
• Version Model Number: 387687
• Catalog Number: 387687
• 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: true
• 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	15099590231842 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033038

FDA Product Code

• NIG: System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-01-08
• Device Publish Date: 2016-09-09

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