Visit: diagnostics.us.tosohbioscience.com/analyzers/g8 [www.diagnostics.us.tosohbioscience.com/analyzers/g8]
The Tosoh G8 was initially cleared by the agency in 2008 as a diabetes monitoring device. The intended use has now been expanded so the Tosoh G8 can be used for screening as well. The ADA Clinical Practice Recommendations state that HbA1c can be used to diagnose diabetes using a NGSP-certified method and a cutoff of HbA1c l6.4%.
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