FDA clears Mindray’s hematology analyzer
Mindray has received 510(k) clearance from the Food and Drug Administration to market and sell the Mindray BC-3600 Auto Hematology Analyzer. The analyzer is designed to meet the testing needs of small and mid-volume hematology laboratories while offering features commonly found on large volume analyzers.
The BC-3600 Hematology Analyzer features closed-tube sampling via a single push button. The large 10.4-inch color touchscreen allows visibility from all angles. Hemoglobin analysis is performed using cyanide-free reagents. The analyzer processes up to 60 samples per hour and stores up to 40,000 results with histograms. The barcode reader and optional LIS connectivity enables seamless sample data transmission. Nearly all scheduled maintenance procedures are automated by touch buttons.
“We are excited to launch the BC-3600 Hematology Analyzer into the United States laboratory market. Mindray enjoys satisfied customer experiences with this analyzer outside of the U.S. and looks forward to adding U.S. customers to our installed base,” Caroline Li, Mindray IVD North America’s general manager, said in a statement. “As Mindray has grown rapidly in global markets, the commercialization of the BC-3600 Hematology Analyzer further enhances our presence in the U.S. in vitro diagnostic market enabling us to continue to introduce new and innovative products for the clinical laboratory in the future.”
MedTest is the exclusive primary distributor of the BC-3600 Hematology Analyzer in the U.S. and Canada.