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The ThyroChek whole blood, rapid TSH assay is a visual, non-instrument, qualitative, solid-phase, lateral now, immunochromatographic assay for identifiying capillary or venous blood sample contains TSH in a concentration ≥ 5 micro IU/ml. The test is intended for use as an in-vitro diagnostic device by medical professionals to screen for primary hypothryoidism. It is not indicated for use as a screening method for neonatal hypothyroidism.

This new immunometric assay device is a single-use Class II medical device for professional use that is designed to indicate whether a capillary or venous blood sample contains TSH in a concentration ≥ 5 micro IU/ml. The ThyroChek whole blood, rapid TSH assay is a visual, non-instrument, qualitative, solid-phase, lateral now, immunochromatographic assay.