IgE ELISA Test kit - India CDSCO Medical Device Registration
IgE ELISA Test kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2023/000073_d471d19d0710d13f6f72f8d7b67dead0_43e3f37e4bf536f049b2e45e36240ff0. The license holder is Weldon Biotech India Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is Uttarakhand.
This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
License Holder
Weldon Biotech India Pvt. Ltd.Device Class
Approving Authority
Uttarakhand
Product Information
IgE constitutes a fraction of the total antibody in serum 50-300 ng/mL (NA) and together with its Fc receptor is important in primary immune responses. The immunogenetic mechanisms underlying IgE responsiveness seen in the atopic diseases can be divided into antigen-specific and non-antigen-specific responses. IgE antibodies to common antigens are reported in the serum of 13% of normal blood donors. Autoantibodies to the IgE Fc-epsilon-RII (NA) reported in the sera of patients with chronic urticaria, can induce histamine release from mast cells. Patients with atopic allergic diseases such as atopic asthma, atopic dermatitis, and hay fever have been shown to exhibit increased total immunoglobulin E (NA) levels in blood. Certain groups of white blood cells, including basophils and tissue mast cells, have membrane receptors for the IgE molecule. IgE can be assayed in the range of 0 โ 200 lU/ml using 25 ฮผl serum sample
