Total IgE Rapid Test Cassette (Serum/Plasma)

Primary DI

D-GGIGE-302aX2

Basic UDI-DI Code

B-GGIGE-302aX2

Reference

GGIGE-302a

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Zhejiang Orient Gene Biotech Co., Ltd

Allergy is a common health problem, affecting approximately 20-25 ％ of people with immediate-type hypersensitivity reactions that manifest in the form of rhinitis, urticaria， dermatitis, gastrointestinal illness, wheezing and rarely anaphylactic shock. This immediate (atopic anaphylactic) type of allergy is mediated by allergen-specific lgE antibodies. Allergen-specific lgE antibodies are produced by the immune system in response to allergic sensitization. These antibodies both circulate in the bloodstream and also bind to the surface of mast cells and basophils. When allergens later bind to the surface lgE molecules，they trigger the cellular release of histamines and other agents causing typical allergic symptoms including rhinitis (hay fever)，wheezing, urticaria (hives) and atopic dermatitis (skin rash). Rapid detection of elevated levels of lgE using the Total IgE Rapid Test Cassette (Serum/Plasma) will help in the diagnosis and treatment of lgE-mediated allergic and autoimmune disorders. The Total lgE Rapid Test Cassette (Serum/Plasma) is an immunochromatographic assay which utilizes immobilized and dye-conjugated monoclonal antibodies against human lgE to selectively identify elevated lgE levels with a high degree of sensitivity.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).