CDSCO UID MFG/IVD/2023/000073_c82ab9fc6c3f118e8368100321eaf3fe_4d93fdc4ed8086275cd9e24840d0d310
Anti-Tissue Transglutaminase ELISA Test Kit
Weldon Biotech India Pvt. Ltd.·Device Class Class B·India CDSCO
Registration details
- UID
- MFG/IVD/2023/000073_c82ab9fc6c3f118e8368100321eaf3fe_4d93fdc4ed8086275cd9e24840d0d310
- Device class
- Class B
- License holder
- Weldon Biotech India Pvt. Ltd.
- Approving authority
- Uttarakhand
- Product information
- Anti Tissue Transglutaminase is an indirect solid phase enzyme immunometric assay (NA) kit designed for the quantitative measurement of IgA class antibodies directed against tissue transglutaminase in human serum or plasma. The assay is intended for in vitro diagnostic use only as an aid in the diagnosis of celiac disease and dermatitis herpetiformis. Anti Tissue Transglutaminase IgA test is based on the binding of serum or plasma antibodies on the human recombinant tissue transglutaminase coated into the microplates. The antibodies in calibrators, controls or prediluted patient samples bind into the inner surface of the wells. After a 30 minutes incubation the microplate is washed with wash buffer for removing non-reactive serum components. An anti-human-IgA horseradish peroxidase conjugate solution recognize IgA class antibodies bound to the immobilized antigens. After 30 minutes incubation any excess enzyme conjugate, which is not specifically bound is washed away with wash buffer. A chromogenic substrate solution containing TMB is dispensed into the wells. After 15 minutes of incubation the color development is stopped by adding the stop solution. The solutions color change into yellow. The amount of color is directly proportional to the concentration of IgA antibodies present in the original sample
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About this record
Anti-Tissue Transglutaminase ELISA Test Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2023/000073_c82ab9fc6c3f118e8368100321eaf3fe_4d93fdc4ed8086275cd9e24840d0d310. The license holder is Weldon Biotech India Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is Uttarakhand.
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