ACCESS HIV Ag/Ab combo QC C39452

GUDID 15099590745172

The Access HIV Ag/Ab combo QC is intended for monitoring system performance of the Access HIV Ag/Ab combo assay. The Access HIV Ag/Ab combo QC is for use on the DxI 9000 Access Immunoassay Analyzer.

Beckman Coulter, Inc.

HIV1/HIV2 antigen/antibody IVD, control

• Primary Device ID: 15099590745172
• NIH Device Record Key: 60e1145e-1536-425c-9c25-621cb1a17c05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACCESS HIV Ag/Ab combo QC
• Version Model Number: C39452
• Catalog Number: C39452
• 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	15099590745172 [Primary]

FDA Product Code

• MJY: Kit, Serological, Negative Control

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-25
• Device Publish Date: 2024-03-15

Devices Manufactured by Beckman Coulter, Inc.

• 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
• 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