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Echo Lumena is Immucor's fifth-generation immunohematology instrument, and with the fully automated NEO platform, they offer a standardized workflow solution for laboratories.
The push-button device, which works by firing an array of microneedles into an individual's arm, was cleared by the FDA last year.
BD and the FDA said that a chemical called thiuram found in certain BD blood collection tubes may render results from Magellan's LeadCare blood lead tests inaccurate.
The firm aims to have its test on the European clinical market by early next year, followed by a launch in the US.
The firm offers a high-throughput, automated and a low-throughput, manual solution and now plans to address mid-range needs with two new instruments.
Despite the FDA approval, Oxford Immunotec could still exit the business of blood screening for babesia, one analyst said.
The test from Banyan Biomarkers called the Brain Trauma Indicator measures the levels of the proteins UCH-L1 and GFAP that are released into the blood.
McKesson will exclusively distribute Sysmex's XW-100 system, a CLIA-waived complete blood count diagnostic instrument starting in the spring.
Bio-Rad received 510(k) clearance for its IH-Incubator L and IH-Centrifuge L instruments for use with the company's full range of IH-System Gel Reagents.
The FDA said it observed a number of violations of federal law related to the company's Vacutainer blood collection tubes during an inspection.