Abbott Afinion 2 Multi-Assay Biochemistry Analyzer - (1116681)

The Abbott Afinion 2 Multi-Assay Biochemistry Analyzer is a compact, rapid, multi-assay diagnostic device engineered for efficient and accurate point-of-care testing. It is designed to deliver valuable near-patient test results in minutes, facilitating timely clinical decision-making and enhancing patient care.

This analyzer performs quantitative determinations of multiple analytes, including HbA1c, Lipid Panel, ACR, and CRP, from various sample types such as whole blood, urine, or plasma. The system utilizes all-in-one test cartridges, each containing an integrated sample collection device and all necessary reagents for a single test, streamlining the analytical workflow.

Intended for in vitro diagnostic use, the Afinion 2 Analyzer holds regulatory approvals including CE marking, demonstrating conformity to the European IVD regulation (EU) 2017/746 and RoHS 2 directive. It also has received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) for HbA1c and ACR testing, and is classified as a CLIA Moderate Complexity Analyzer.

Key Features : 

Quantitative determination of HbA1c, Lipid Panel, ACR, and CRP
Designed for point-of-care testing
Utilizes boronate affinity assay principle for HbA1c measurement
CE marked under EU 2017/746 IVD regulation and RoHS 2 directive
FDA 510(k) cleared for HbA1c and ACR testing
Classified as a CLIA Moderate Complexity Analyzer