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Immunoglobulin M testing Kit - India CDSCO Medical Device Registration

Immunoglobulin M testing Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000117_be476321e146609e6d6c44e0bbb36d9f_f6d2a8fba171ccf0a511c50c587bfd0b. 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.

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.

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CDSCO Registered
Class Class B
Immunoglobulin M testing Kit
UID: MFG/IVD/2022/000117_be476321e146609e6d6c44e0bbb36d9f_f6d2a8fba171ccf0a511c50c587bfd0b

Brand Name

Cellpro

Device Class

Class B

Approving Authority

Haryana

Product Information

Immunoglobulin M (Cellpro) are the most primitive and least specializedimmunoglobulin; they are the only one that a neonate normally synthesizes. B lymphocytes at first have IgM surface receptors and secrete IgM in the first (Cellpro) to the presence of an antigen. The heavy chains of the IgM surface receptor molecules then are modified in situ to IgG or IgA heavy chains, but the variable regions remain unchanged; as the cells change into plasma cells, a second dose of the same antigen causes a larger, secondary response, now of IgG secretion. IgM continues, however to be synthesized against antigens confined to the blood, such as erythrocyte surface antigens and tropical parasites. IgM contains about 10% of carbohydrates. They are about 5-10% of all circulating immunoglobulins; IgM are monomeric as membrane receptor molecules. But most of the serum IgM is a pentamer-examer of five-six IgM monomers. In this last case, IgM presents an elevated molecular weight that prevents its passage into extravascular spaces. IgM are not transported across the placenta and are therefore not involved in hemolytic disease of neonates. They are also a very efficient complement activator, as Fc chains are spaced at the correct distance to match the C1q binding sites. IgM is important in the first immuno response to infections, to immunodeficiency and to myeloma. High levels in the serum are found in bile chronic cirrhosis and in intrauterine infections

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