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Anti-tissue Transglutaminase IgG (Maglumi Anti-tissue Transglutaminase IgG ) - India CDSCO Medical Device Registration

Anti-tissue Transglutaminase IgG (Maglumi Anti-tissue Transglutaminase IgG ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000036_c1ab1a576bfcb48dfecc1528320940b7_e37da1859ecc5292f5ba7656fee0c679. This device is marketed under the brand name MAGLUMI® Tip. The license holder is SNIBE DIAGNOSTIC (India) Private Limited., and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered
Class Class B
Anti-tissue Transglutaminase IgG (Maglumi Anti-tissue Transglutaminase IgG )
UID: IMP/IVD/2023/000036_c1ab1a576bfcb48dfecc1528320940b7_e37da1859ecc5292f5ba7656fee0c679

Brand Name

MAGLUMI® Tip

Device Class

Class B

Approving Authority

CDSCO

Product Information

The kit is an in vitro chemiluminescence immunoassay for the quantitative determination of Anti-tissue Transglutaminase IgG (MAGLUMI® Tip) in human serum and plasma using the MAGLUMI series Fully-auto chemiluminescence immunoassay analyser and Biolumi series Integrated System, and the assay is used for an aid in the differential diagnosis of celiac disease

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DJ Fang

DJ Fang

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