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BD Leucocount™ Kit

A trusted CE-IVD solution with an efficient workflow on the BD FACSLyric™ Flow Cytometer to enumerate and help deliver safety of blood transfusion products.

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Features

The trusted performance of the BD Leucocount™ Kit

  • For in vitro diagnostic use on the BD FACSLyric™ Flow Cytometer
  • Utilizes BD Trucount™ Tube technology for an accurate and reproducible single-platform assay
  • Provides equivalent results on the BD FACSLyric™ Flow Cytometer as on the BD FACSVia™ Flow Cytometer
  • Offers sensitivity (Limit of Quantitation of 0.7 rWBC cells/µL) that aligns with leukoreduction guidelines
  • Delivers linear results over a range from 0.7 – 350 rWBC cells/µL
  • Has been validated for age of specimen of up to 48 hours from leucoreduction

The efficient workflow on the BD FACSLyric™ Flow Cytometer

  • Enables an efficient and intuitive workflow when used with the BD Leucocount™ Kit and BD Leucocount™ RBC and PLT Controls
  • Easily integrated into existing assay menu and workflow on the BD FACSLyric™ Flow Cytometer
  • Delivers high-throughput capability with acquisition using the BD FACS™ Universal Loader
  • Simplifies analysis with pre-defined templates, lab reports, automated gating and LIS integration
  • Features relevant to 21 CFR Part 11 with audit trail and e-signatures

Applications

The BD Leucocount™ Kit achieves reliable enumeration of residual white blood cells with a standardized CE-IVD assay
LOT1 HOL Leucocount R01 1 R6 Lab Report
LOT1 HOL Leucocount R01 1 R6 Lab Report
The BD Leucocount™ Kit provides sensitivity that aligns with leucoreduction guidelines
LC Linearity in RBC and Platelet Aalysis
LC Linearity in RBC and Platelet Aalysis



The BD FACSLyric™ Flow Cytometer is a Class 1 Laser Product.

BD FACSLyric™ Flow Cytometer with the BD FACS™ Universal Loader, BD FACSuite™ Clinical and BD FACSuite™ Applications is an in vitro diagnostic medical device bearing a CE mark.

BD Leucocount™ Kit and BD Leucocount™ RBC and PLT Controls are in vitro diagnostic medical devices bearing a CE mark and are CE certified by BSI Group the Netherlands B.V.