Clinical chemistry hormone IVDs

Intended purpose

Bébé Bloom offers a range of different self-performing IVD urine tests for the detection of pregnancy and ovulation. Two of the tests assess the qualitative determination of human chorionic gonadotropin hormone (HCG). The sensitivity offered is 10mIU/mL and 25mIU/mL. The GMDN number is 33819. Also, we offer a semi-quantitative ovulation test, which detects the luteinizing hormone (LH). The test assists to predict the surge of the hormone, which leads to ovulation. The GMDN number is 54255