CDSCO UID MFG/IVD/2023/000073_d471d19d0710d13f6f72f8d7b67dead0_43e3f37e4bf536f049b2e45e36240ff0
IgE ELISA Test kit
Weldon Biotech India Pvt. Ltd.·Device Class Class B·India CDSCO
Registration details
- UID
- MFG/IVD/2023/000073_d471d19d0710d13f6f72f8d7b67dead0_43e3f37e4bf536f049b2e45e36240ff0
- Device class
- Class B
- License holder
- Weldon Biotech India Pvt. Ltd.
- 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 – 200 lU/ml using 25 μl serum sample
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About this record
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.
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