Clinical chemistry-specific protein IVDs

Intended purpose

ALEX³ Allergy Xplorer is a test kit used for in-vitro examination of human serum or plasma (exception EDTA-plasma) to provide information to aid the diagnosis of patients suffering from IgE-mediated diseases in conjunction with other clinical findings or diagnostic test results. The IVD medical device detects allergen-specific IgE (sIgE) quantitatively and total IgE (tIgE) quantitatively in the range from 2 - 1000 kU/l (semi-quantitative 1001-2500 kU/l). The product is used by trained laboratory personnel and medical professionals in a medical laboratory.