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Immunoglobulin A testing Kit - India CDSCO Medical Device Registration

Immunoglobulin A testing Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2022/000117_a9f8d1fbbdcda517ffe4fb1bd669c4b0_0225d2ddc62d09fe61f31a67a4c8f814. 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 A testing Kit
UID: MFG/IVD/2022/000117_a9f8d1fbbdcda517ffe4fb1bd669c4b0_0225d2ddc62d09fe61f31a67a4c8f814

Brand Name

Cellpro

Device Class

Class B

Approving Authority

Haryana

Product Information

Imunoglobulin A (Cellpro) are a particular type of antibodies, molecules involved inthe immune answer of the human being. Approximately 10-15% of all serum immunoglobulin is IgA. IgA contains 10% carbohydrate with a molecular weight of 160 000 and has an half-life of 6 days. In its monomeric form, its structure is very similar to that of IgG, but 10-15% of IgA in serum is polymeric. On electrophoresis IgA migrates in the region, ahead of most of the IgG. Another and possibly more important form of IgA is called secretory IgA. It is found in tears, sweat, saliva, maternal milk, colostrum, gastrointestinal and bronchial secretions. Secretory IgA has a molecular weight of 380 000 and consists of two molecules of IgA, a secretory component whose molecular weight is 70 000 and a J-chain of 15 600. The secretory component makes secretory IgA more resistent to enzymes, allowing it to protect the mucosa from bacteria and viruses at the level of gastrointestinal and respiratory system, the contact points between inside and outside areas in the human beings. Secretory IgA is synthesized mainly by plasma cells in the mucous membranes of the gut, bronchi and in the ductules of a lactating breast. They are involved in two very important functions: mucous membrane immunity and neonatal immunity. In the neonatal immunity their importance is due to their ability to transmit the first defensive line from the mother to neonates; during the first months of life, neonates are unable to produce its own antibodies. In the colostrum and in the milk of the mother there are high concentrations of IgA, able to protect the gastrointestinal system from intestinal infections. IgA can activate complement by the alternative pathways, but the exact role of the IgA in serum is not completely clear. The determination of IgA is important for the typing of immunodeficiency and in myeloma. It also has a function in the acute and chronic infections. Increased values could be present in the acute and chronic hepatities, in alcoholic cirrhosis and chronic infections

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