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The CELL-DYN® 4000 System with ImmunoPlt (CD61) Assay is a multi-parameter, automated. hematology analyzer designed for in-vitro diagnostic use in clinical laboratories.
The CELL-DYN® 4000 System with ImmunoPlt (CD61) Assay is a fully automated hematology analyzer, including reporting of the ImmunoPlt (CD61) count, intended for in-vitro diagnostic use in the clinical laboratory of a hospital, medical clinic, or reference laboratory.

The CELL-DYN® 4000 System has five main modules: the Analyzer, which aspirates, difutes and analyzes each whole blood specimen; the Autoloader, which automatically identifies, mixes, and presents specimens for processing; the Pneumatic Unit, which controls fluid movement in the Analyzer and tube movement in the Autoloader; the Data Station, which controls all system processing and provides the primary operator interface with the system; and the Color Printer, which generates reports automatically or on demand.
The CELL-DYN 4000 System with ImmunoPlt (CD61) Assay is designed to analyze EDTAanticoagulated whole blood specimens and report the hematological parameters shown in the table on the following page.

The provided text describes the CELL-DYN® 4000 System with ImmunoPlt™ (CD61) Assay, a multi-parameter automated hematology analyzer.

Here's an analysis of the acceptance criteria and study data based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the "Equivalency Data" section "shows performance to manufacturer's specifications." However, the specific acceptance criteria (numerical thresholds) or the detailed reported performance values are not explicitly listed in the provided text. The text only broadly concludes that the data supports substantial equivalence to predicate devices and microscopy for low platelet counts.

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