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The MyAllergyTest® is for the collection and transport of a capillary blood sample to a clinical laboratory for allergen specific IgE profile testing. The MyAllergyTest® is intended for use with the MyAllergyTest® system. The MyAllergyTest® is intended for home use.

MyAllergyTest ® is a Sample Collection Kit containing the materials necessary to collect and mail a capillary blood sample to a clinical laboratory for allergen specific IgE profile testing. The device modification is to revise the limitations statement to allow testing of the whole blood sample for up to 30 days following collection. Currently the limitations states 10 days. No changes to the kit components.

The ImmuneTech™ Total IgE System is a quantitative in vitro diagnostic test system that measures total IgE in human serum. The ImmuneTech™ Total IgE System is intended for clinical laboratory use. The ImmuneTech™ Total IgE System may only be run on the Luminex 100TM Integrated System. The ImmuneTech™ Total IgE System is a quantitative in vitro diagnostic test system used as an aid in the clinical diagnosis of IgE mediated allergic disorders.

ImmuneTech™ Total IgE System is a test for the measurement of total IgE in human serum. The ImmuneTech™ Total IgE System consists of two components. - 1. Flow Cytometer instrument with software for ImmuneTech™ Total IgE System - 2. ImmuneTech™ Total IgE System Reagents A serum sample is mixed with anti-IgE coupled microspheres. If present, IgE in the sample will bind with the microspheres and form an anti-human IgE / IgE complex. This complex is then sequentially incubated with biotin-labeled-anti-human IgE antibody and fluorescent-labeled-streptavidin. If IgE is present in the sample, the final sandwich complex of anti-human IgE / IgE / biotin-anti IgE / fluorescent-streptavidin will form. Measurement of the fluorescent signal from the sandwich complex is directly proportional to the concentration of total IgE in the sample. The flow cytometer with ImmuneTech ™ Total IgE System specific software will measure total IgE concentrations.

The MyAllergyTest™ is for the collection and transport of a capillary blood sample to a clinical laboratory for allergen specific IgE profile testing. The MyAllergyTest™ is intended for use with the MyAllergyTest™ System. The MyAllergyTest™ is intended for home use by the lay consumer (Over-the-Counter).

MyAllergyTest™ is a Sample Collection Kit containing the materials necessary to collect and mail a capillary blood sample to a clinical laboratory for allergen specific IgE profile testing.

The MyAllergyTest System is a quantitative in vitro diagnostic test for the measurement of allergen specific IgE antibodies in human serum samples. The MyAllergyTest System may only be run on the Luminex 100TM Integrated System Version 2.0. The MyAllergyTest™ System is used as an aid in the clinical diagnosis of IgE mediated allergenic disorders. Measurement of allergen specific IgE antibodies may aid diagnosis of asthma, allergies, and other pulmonary disorders.

MyAllergyTest™ System is a test for the measurement of allergen specific IgE in human serum. The MyAllergyTest™ System consist of two components: 1. MyAllergyTest™ System Reagents. 2. MyAllergyTest™ System support software for the Luminex 100m I S Version 2.0 A serum sample is mixed with allergen specific coupled microspheres. If present, specific IgE in the sample will bind with the microspheres and form an allergen/sIgE complex is then sequentially incubated with biotical ati-human IgE antibody and fluorescent-labeled-streptavidin. sequentially is present in the sample, the final sandwich complex of allergen/slgE/biotin-anti-It specific is the summers, Measurement of the fluorescent signal from the sandwich complex is directly proportional to the concentration of allergen specific IgE in the sample. The MyAllergyTest System may only be run on the Luminex 100m Intergented System Version 2.0. The MyAllergyTest™ System specific software for the Luminer 100m Integrated System Version 2.0 will simultaneously measure and identify allergen specific IgE concentrations.