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.

• 15099590732103 - DxI 9000 Access Immunoassay Analyzer: 2024-10-28The 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.
• 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
• 15099590575243 - Access hLH: 2024-05-01 The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing
• 15099590760823 - Access NT-proBNP: 2024-04-29 The Access NT-proBNP assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of N-term
• 15099590760830 - ACCESS NT-proBNP CALIBRATORS: 2024-04-29 The Access NT-proBNP Calibrators are intended to calibrate the Access NT-proBNP assay for the quantitative determination of N-te
• 15099590772840 - Access Ferritin: 2024-04-15 The Access Ferritin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of ferriti
• 15099590745158 - ACCESS HIV Ag/Ab combo: 2024-03-25 The Access HIV Ag/Ab combo assay is a paramagnetic particle, chemiluminescent immunoassay for the simultaneous qualitative in vi
• 15099590745165 - ACCESS HIV Ag/Ab combo Calibrators: 2024-03-25 The Access HIV Ag/Ab combo Calibrators are intended to calibrate the Access HIV Ag/Ab combo assay for the simultaneous qualitati
• 15099590745172 - ACCESS HIV Ag/Ab combo QC: 2024-03-25 The Access HIV Ag/Ab combo QC is intended for monitoring system performance of the Access HIV Ag/Ab combo assay. The Access HIV