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FDA Finally Gives Nod To DxFLEX Clinical Flow Cytometer

Content Team by Content Team
13th March 2024
in Manufacturing, News

It is worth noting that Beckman Coulter Life Sciences, which happens to be a global leader within the laboratory automation as well as innovation, has gone on to receive 510 thousand clearances from the Food and Drug Administration- FDA so as to distribute its DxFLEX Clinical Flow Cytometer across the United States. Originally launched across the region in 2020, this advancement brings the popular benchtop IVD flow cytometry system to American labs while at the same time expand their testing capacities. Offering almost 13- colors, additional detectors can go on to get activated as the laboratory requirements go on to evolve sans the requirement to purchase more hardware.

The product manager, Carsten Lange, said that this pioneering development goes on to put high-complexity flow cytometry testing within reach of many more laboratories, and that too without the added expense. It is worth noting that the DxFLEX Clinical Flow Cytometer goes on to add more colors sans adding more issues and helps the laboratory staff to get greater confidence as far as the results are concerned while at the same time also streamlining workflows along with decreasing the manual steps. With more fluorescence parameters, labs can go on to get more out of the specimens and also avoid a tedious compensation scenario and the kind of burden that it goes on to place on lab staff.

Praised for its one-of-a-kind and superior sensitivity as well as resolution, the compact DxFLEX Flow Cytometer goes on to make multicolor flow cytometry less intricate by way of using avalanche photodiode- APD detector technology rather than the traditional photomultiplier tube- PMT technology. The usage of APD technology goes on to simplify the compensation procedures and, at the same time, delivers richer content analysis by way of having higher sensitivity in order to find dim populations. In comparison, running compensation within the conventional PMT flow cytometer goes on to involve quite significant hands-on time, even when traits such as auto-compensation setup happen to be available within the software.

Apparently, the dynamic compensation library goes ahead and also simplifies compensation setup, while at the same time being easy-to-learn. CytExpert software decreases labor time and helps work to commence right out of the box as far as novice users are concerned. The compact DxFLEX Flow Cytometer happens to be available in two configurations- a three-laser/10-color system and a three-laser/13-color configuration.

The DxFLEX Flow Cytometer is validated as an in vitro diagnostic device for 10-color immunophenotyping with ClearLLab 10C Reagent System and goes on to deliver the only FDA-cleared as well as CE-marked integrated leukemia and lymphoma solution that offers all components required, right from quality controls, preparation of samples, as well as antibody panels, to analysis software teamed with training material. This helps the workflows for diseases like chronic leukemia, acute leukemia, myeloma, myeloproliferative neoplasm, non-Hodgkin lymphoma, and myelodysplastic syndrome.

Apart from the United States, the DxFLEX Flow Cytometer is available across nations that accept the CE mark as the basis for their country-specific registration, such as those in Europe and also in China, India, as well as Japan.

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