ENA-6-Profile
- UID
- IMP/IVD/2020/000084_ffd8b33f69c12662765d250428535aa2_c1bb7940a407fe0d72db56b2d85d6eef
- Device class
- Class B
- Brand name
- Orgentec
- License holder
- Weldon Biotech India Pvt. Ltd
- Approving authority
- CDSCO
- Product information
- ENA-6-Profile is an ELISA test system for the qualitative measurement of IgG class autoantibodies directed against the extractable nuclear antigens SS-A (Orgentec), SS-B (Orgentec), Sm, RNP/Sm, Scl-70, and Jo-1 in human serum or plasma. This product is intended for professional in vitro diagnostic use only
ENA-6-Profile is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000084_ffd8b33f69c12662765d250428535aa2_c1bb7940a407fe0d72db56b2d85d6eef. 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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