Mindray and MedTest Announce FDA 510(k) Clearance for the BC-3600 Hematology Analyzer

Mindray has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) to market and sell the new Mindray BC-3600 Auto Hematology Analyzer. The Mindray BC-3600 Analyzer meets the testing needs of small and mid-volume hematology laboratories while offering state-of-the-art 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 maximum 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. The intuitive software enhances workflow efficiency and offers the operator a pleasant user experience.

Caroline Li, General Manager of Mindray IVD North America, stated: “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 US and looks forward to adding US customers to our installed base. As Mindray has grown rapidly in global markets, the commercialization of the BC-3600 Hematology Analyzer further enhances our presence in the US 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 US and Canada. Hanjoon Ryu, CEO of MedTest, stated: “Low and Mid-volume laboratories desire a provider who offers innovative instruments with proven quality reagents, superior customer support and recognized economic advantages across multiple laboratory disciplines. Partnered with the bench-top BS-200 Chemistry Analyzer or the BS-480 Chemistry Analyzer, the addition of the BC-3600 Hematology Analyzer enables MedTest to offer a total testing solution that meets the requirements of both the hematology and chemistry laboratories. We are delighted to share this announcement with our strategic partner, Mindray.”