Mindray, Mahwah, NJ, and MedTest, Canton, Mich, recently announced that they have received FDA premarket notification (510(k)) clearance to market and sell the Mindray BA-800M clinical chemistry analyzer.
Meeting the testing needs of mid- and high-volume laboratories, the BA-800M chemistry analyzer produces 800 photometric test results per hour with an overall throughput of 1200 tests per hour with ion-selective electrode. A sample delivery module provides a sample capacity of 440 positions, while the system’s reagent consumption design minimizes reagent use per test and reduces reagent bottle dead volume.
Advanced features include continuous reagent loading, reagent bubble detection, water quality monitor, one-key stat touch button, probe liquid level detection, and sample probe clot and collision recovery.
“As Mindray has grown rapidly in global markets, the commercialization of the BA-800M clinical chemistry analyzer further enhances our growth and 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,” says Caroline Li, general manager of Mindray IVD North America. “Mindray enjoys satisfied customer experiences with this analyzer outside of the United States and looks forward to adding US customers to our installed base.”
MedTest is the analyzer’s exclusive US distributor, including manufacturing and distribution of reagents, calibrators, and quality control products for the general chemistry and urine drugs of abuse screening markets.
“The introduction of the BA-800M analyzer is another example of our continuous focus on scalable solutions for the diagnostic laboratory in the United States,” says Hanjoon Ryu, CEO of MedTest. “Partnered with the benchtop BS-200 chemistry analyzer and the BS-480 analyzer, the BA-800M analyzer enables MedTest to offer a unique and scalable testing solution for the integrated delivery networks and group purchasing organizations in the United States. Our solutions will provide commutable testing results across the large core laboratory and the smaller satellite laboratory.”
