Pharmaceuticals company Roche (SIX:RO)(OTCQX:RHHBY) reported on Thursday the receipt of the 510(k) clearance from the US Food and Drug Administration (FDA) for its new integrated digital hematology testing solution, the cobas m 511 analyzer.
The company's new cobas m 511 analyzer is a combination of a cell countre, slide maker, stainer and a digital morphology analyzer into one integrated solution. The upgraded version features a patented Bloodhound technology to address the challenges of hematology testing.
In conjunction, the patented Bloodhound technology uses only 30μl of blood to print a monolayer onto the slide, stains with an improved method for further analysis of the morphology and enables classification of cells displayed on a viewing station, added the company.
Following the US FDA approval, the laboratories can report the complete blood count (CBC), white blood cell differential and reticulocyte results as well as prepare, stain and analyze blood smears for abnormal results through a single, integrated process. The clinicians will benefit from integrated workflow and faster access to abnormal results.
Hematology is practised by specialists in the field who deal with the diagnosis, treatment and overall management of people with blood disorders ranging from anemia to blood cancer, concluded the company.
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