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Braun Omnitest 5

Device Name:Omnitest 5
Manufacturer:B. Braun Melsungen AG, Carl-Braun-Stra├če, 134212 Melsungen, GERMANY.
Measuring functions:Blood glucose
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Finger
Measurement Occurrence:Single measurements only
Availability:Discontinued but still available
Assessment:

The technology used in the Braun Omnitest 5, to measure blood glucose, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.

Accuracy AssessmentRecommendationBasis
Medaval★★ RecommendationRecent clinical validation; recent protocol
MDR CriteriaSelf-measurementPublished evidence

Validation Publications

Jeon K, Shin M. Performance Evaluation of B. Braun Omnitest 5 Blood Glucose Monitoring System for Self-Monitoring of Blood Glucose. J Lab Med Qual Assur. 2016 Dec;38(4):234-42. doi: 10.15263/jlmqa.2016.38.4.234. Available from: www.jlmqa.org.

15197:2013 - Pass General population