BioLISA FIgG Reagent Kit

Primary DI

06924030412494

Basic UDI-DI Code

B-06924030412494

Reference

MB00288

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

HOB Biotech Group Corp., Ltd.

The BioLISA FIgG Reagent Kit is for measuring the relative amount of food-specific IgG antibody to 80 foods in human serum. The values obtained must always be correlated with the clinical presentation, since elevation of a certain food-specific antibody by itself does not necessarily mean disease. This kit does not provide information about IgE-mediated allergies. It is intended for in vitro diagnostic use and is to be used in clinical laboratories for professional use. The topic of food intolerance and the role of food and food additives as causative factors in food hypersensitivity diseases have prompted a considerable interest for many years. Commonly implicated foods include cow's milk, eggs, wheat, corn, chocolate, nuts, soybean, and shellfish. About 0.5% of infants may have a hypersensitivity reaction to cow’s milk. Research studies suggest that in a child with proven food hypersensitivity, the probability of food hypersensitivity in subsequent siblings is increased up to 50%. Most of the foods that belong to one group may share common allergenic properties, and sometimes foods of two different groups may also show cross-reactive allergic reactions. To reduce certain food intolerance reactions, cooked foods may be recommended because cooked food can be less allergenic than raw food. Most common food allergy symptoms are gastrointestinal related and may include nausea, diarrhea, and abdominal pain. The clinical manifestations of food intolerance also include classic allergic symptoms such as anaphylaxis, allergic rhinitis, atopic dermatitis, and urticaria. The role of food intolerance in conditions such as migraine headaches and allergic tension fatigue syndrome is controversial. It is important to remember that the symptoms of food intolerance, especially gastrointestinal symptoms, can be mimicked by a variety of other conditions.

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