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Achieve complete compliance with 21 CFR Part 11

Logos Biosystems
28 Apr 2022

In this product brochure, discover the CountWireTM System for the LUNA-FX7TM, designed to allow users to access data from one or more devices, no matter where they may be located.

To ensure the accuracy, reliability, authenticity, and consistency of electronic records the United States Food & Drug Administration established Title 21 also known as 21 CFR Part 11, to regulate electronic records and electronic signatures. The CountWireTM System completely supports 21 CFR Part 11 compliance, enabling the LUNA-FX7TM Automated Cell Counter to be used in a regulated process as outlined in this product brochure.

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LUNA-FX7™ Automated Cell Counter

Logos Biosystems

The LUNA-FX7™ is our most powerful cell counter to date, with unmatched cell counting accuracy, new 1, 3 and 8-chamber slide options, state of the art optics, dual fluorescent and brightfield detection, and precision autofocus. The LUNA-FX7™’s new features such as the Bioprocess mode, Quality Control mode, and the CountWire™ (21 CFR Part 11 compliant) software will help companies and facilities meet and surpass quality and regulatory requirements.

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Flow Cytometry / Cell CountingFlow cytometers are used to count, sort and examine multiple characteristics of cells. Other cell analysis equipment includes image cytometers, cell counters, fluorescence-activated cell sorters (FACS), magnetic-activated cell sorters (MACS), and a range of flow cytometry assay kits. Flow cytometers can reveal information on cell viability, cell proliferation, apoptosis and cell cycle progression, as well as identify cell populations and intracellular or cell-surface molecules. Additionally, some flow cytometers, known as FACS, have an additional sorting function after analysis. Cell counters and image cytometers count live and dead cell populations and can also conduct cell proliferation assays. Find the best flow cytometers, cell counters and cell sorters in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Electronic Laboratory NotebooksElectronic Laboratory Notebooks (ELNs) are becoming increasingly popular for documenting experimental processes and for lab data management. An ELN is informatics software which can be biology specific, chemistry specific, cross-disciplinary or web-based. Advantages of an electronic lab notebook include increased data protection, efficiency and straightforward data searching and sharing.Quality ControlQuality control is needed in all production processes. Quality control is a monitoring procedure or set of procedures that are put in place to ensure that a manufactured product adheres to a defined set of quality criteria. AutomationAutomation in laboratories and manufacturing processes enhances efficiency, precision, and scalability by reducing the need for manual intervention. It plays a critical role in improving productivity, minimizing human error, and accelerating workflows in fields like diagnostics, drug development, and industrial testing. Automation technologies include robotic systems, automated liquid handlers, and process control systems that streamline complex tasks and ensure consistent, reproducible results. Explore our peer-reviewed product directory to discover the best automation solutions, compare options, read user reviews, and get prices directly from manufacturers.Software Solution

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Achieve complete compliance with 21 CFR Part 11