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BTNX Rapid Response Gluco-MD (04GLU-67NC)
Device Name:
Rapid Response Gluco-MD
Device Model:
04GLU-67NC
Manufacturer:
BTNX Inc., Unit 23, 570 Hood Road, Markham, ON L3R 4G7, CANADA.
Measuring functions:
Blood glucose
Primary Client Use:
Intended for professional use
Measurement Site:
Finger
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The BTNX Rapid Response Gluco-MD (04GLU-67NC) is an automatic blood glucose meter. The accuracy of its blood glucose measurement technology has yet to be proven to MDR requirements. Blood glucose measurements are taken from the finger. It is intended for professional use.
Assessment:
While the technology used in the BTNX Rapid Response Gluco-MD (04GLU-67NC), to measure blood glucose, has been assessed, the results of the study have not been published and cannot be verified.
Recommendations:
Accuracy AssessmentRecommendationBasis
BG Medaval None While a clinical validation is claimed, it cannot be checked properly.
BG Institute of Health Economics (CA) General use No evidence provided