DxI 9000 Access Immunoassay Analyzer C11137

GUDID 15099590732103

The DxI 9000 Access Immunoassay Analyzer is an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.

Beckman Coulter, Inc.

Chemiluminescent immunoassay analyser IVD

• Primary Device ID: 15099590732103
• NIH Device Record Key: e7f009ea-a090-4321-8adc-5556da5ecc33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DxI 9000 Access Immunoassay Analyzer
• Version Model Number: C11137
• Catalog Number: C11137
• 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	15099590732103 [Primary]

FDA Product Code

• JJE: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use

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: 2024-10-28
• Device Publish Date: 2022-12-31

Devices Manufactured by Beckman Coulter, Inc.

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• 15099590224301 - Access Vitamin B12: 2025-09-17 The Access Vitamin B12 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of vita
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• 15099590754013 - DxFLEX: 2025-09-10 DxFLEX Flow Cytometer
• 15099590701673 - Access Hybritech PSA: 2025-06-09 The Access Hybritech PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of to
• 15099590701680 - Access Hybritech free PSA: 2025-06-09 The Access Hybritech free PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination
• 15099590763626 - Access Syphilis Reagent: 2025-05-15 The Access Syphilis assay is a paramagnetic particle, chemiluminescent immunoassay for the qualitative detection of total antibo