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

Devices Manufactured by Beckman Coulter, Inc.

• 05099590798218 - DxH: 2025-04-14 Beckman Coulter DxH Slides are 25 x 75 x 1 mm glass microscope slides with white or painted frosted ends, used with the DxH Slid
• 14987666545072 - DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module: 2025-04-08 The DxC 500i Clinical Analyzer combines the DxC 500 AU Clinical Chemistry Analyzer and the Access 2 Immunoassay System into a si
• 14987666545089 - DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module: 2025-04-08 The DxC 500i Clinical Analyzer combines the DxC 500 AU Clinical Chemistry Analyzer and the Access 2 Immunoassay System into a si
• 15099590742331 - DxC 500i Clinical Analyzer, DxC 500i Access 2 Immunoassay Module: 2025-04-08 The DxC 500i Clinical Analyzer combines the DxC 500 AU Clinical Chemistry Analyzer and the Access 2 Immunoassay System into a si
• 15099590209636 - DxH: 2024-11-19 Beckman Coulter DxH Slides are microscopic slides intended to be used to prepare whole blood samples for histological stains and
• 15099590762889 - Stem-Kit Reagents: 2024-11-04 Stem-Kit Reagents
• 15099590762896 - StemTrol Control Cells: 2024-11-04 StemTrol Control Cells
• 15099590732103 - DxI 9000 Access Immunoassay Analyzer: 2024-10-28 The DxI 9000 Access Immunoassay Analyzer is an in vitro diagnostic device used for the quantitative, semi-quantitative, or quali