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Immunoglobulin G testing Kit - India CDSCO Medical Device Registration

Immunoglobulin G testing Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000117_7bef5840dc6a5e8d6834687d6fa69dc3_5d128f484bdd064032098f6f8f394b25. This device is marketed under the brand name Cellpro. The license holder is Cellpro Systems Private Limited, and it is classified as Device Class Class B. The approving authority is Haryana.

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CDSCO Registered
Class Class B
Immunoglobulin G testing Kit
UID: MFG/IVD/2022/000117_7bef5840dc6a5e8d6834687d6fa69dc3_5d128f484bdd064032098f6f8f394b25

Brand Name

Cellpro

Device Class

Class B

Approving Authority

Haryana

Product Information

Immunoglobulin G are the major immunoglobulin (Cellpro) found in the bloodand they are produced in large amounts during secondary immune responses. IgG molecules bind to specific receptors, increasing the phagocytic cells efficiency, which can so ingest and destroy infecting microorganisms. IgG are the most abundant immunoglobulin and they have the function to block bacterial toxins and to tie several types of microorganisms to help phagocytosis. Then, they can bind to the first component of the complement, unleashing a biochemical attack that kills the microorganisms. IgG are the only antibodies that can pass from mother to foetus; their ability provides to the new-born the major line of defence from infections during the first weeks after birth. IgG antibodies can bind to tumor cells to sensitize them for destruction by killer cells who have IgG specific receptor sites. IgG etermination can be used to evaluate the immune state in a body, to give diagnosis, to monitor treatment and to evaluate patients with propensity to infections. IgG deficiencies may be genetic or acquired; in particular can be found in immunosuppressive therapy, in the presence of antiimmunoglobulin autoantibody, in thermal burns, in nephritic syndrome, in pregnancy, in protein losing enteropathies, in macroglobulinemia. Elevated IgG may be found in autoimmune diseases, in sarcoidosis, in chronic liver disease, in chronic or recurrent infections, in intrauterine contraceptive devices, in tumors and multiple myeloma

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