PORTAGE, Mich.--(BUSINESS WIRE)--Thermo Fisher Scientific Inc., the world leader in serving science, today announced that it has received 510(K) clearance from the U.S. Food and Drug Administration (FDA) for five new ImmunoCAP Allergen Component tests for detecting IgE sensitization to hazelnut, walnut and cashew nut proteins (components). The tests are performed on Phadia Laboratory Systems.
ImmunoCAP Allergen Component tests measure a patient’s Immunoglobulin E (IgE) antibody sensitization (allergic sensitization) to individual tree nut proteins called allergen components. Quantifying a patient’s IgE sensitization to these allergen components can help clinicians identify primary nut sensitization and help differentiate it from sensitization due to cross-reactivity. A proper diagnosis can help the clinician develop a more comprehensive management plan.
ImmunoCAP Allergen Component tests measure a patient’s Immunoglobulin E (IgE) antibody sensitization (allergic sensitization) to individual tree nut proteins called allergen components. Quantifying a patient’s IgE sensitization to these allergen components can help clinicians identify primary nut sensitization and help differentiate it from sensitization due to cross-reactivity. A proper diagnosis can help the clinician develop a more comprehensive management plan.
