Clinical chemistry substrate IVDs

Intended purpose

IVDs used on the QuikRead go instrument for the qualitative and/or quantitative determination of clinical chemistry substrates in a clinical specimen, including HbA1c for monitoring long term control of glucose from diabetes mellitus or as an aid in diagnosing diabetes. These assays and controls are intended to be used by trained healthcare professionals in clinical laboratories and/or near-patient/point-of-care testing settings.