CE 0197 Mark
HCG is for qualitative detection of human chorionic gonadotropin (hCG) in urine.

INTENDED USE

HCG Pregnancy Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid for the early detection of pregnancy.

PERFORMANCE CHARATERISTICS

Sensitivity: HCG Pregnancy Test detects hCG concentration of 25 mIU/ml and greater. The test has been standardized to the World Health Organization Third International Standard.

Specificity: The addition of LH (300 mIU/ml), FSH (1000 mIU/ml), and TSH ( 1000 mIU/ml) to negative (0 mIU/ml HCG) and positive (25 mIU/ml hCG) specimens showed no cross-reactivity.

Accuracy: more than 99%...