Anti-Tissue-Transglutaminase IgA - India CDSCO Medical Device Registration
Anti-Tissue-Transglutaminase IgA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000084_8ac6881fe1843a2a54eb02d553652e7b_2991c843f4b0e9f3ca573e13d4a8c54d. This device is marketed under the brand name Orgentec. The license holder is Weldon Biotech India Pvt. Ltd, and it is classified as Device Class Class B. The approving authority is CDSCO.
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Brand Name
Orgentec
License Holder
Weldon Biotech India Pvt. LtdDevice Class
Approving Authority
CDSCO
Product Information
Anti-Tissue-Transglutaminase IgA is an ELISA test system for the quantitative measurement of IgA class autoantibodies to tissue transglutaminase (Orgentec) in human serum or plasma. This product is intended for professional in vitro diagnostic use only
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