Mereteck Diagnostics
This article was originally published in The Gray Sheet
Executive Summary
FDA grants 510(k) clearance for BreathTek UbiT breath test kit for diagnosis of active Helicobacter pylori infection, the primary cause of peptic ulcer disease, the firm announces Feb. 4. Enhancements over the firm's previous-generation UBT and UBT Lite breath tests include using the UbiT IR 300 infra-red spectrophotometer instead of a gas isotope ratio mass spectrometer. Shipments will commence immediately...