ENA-6-Profile - India CDSCO Medical Device Registration

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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CDSCO Registered

Class Class B

ENA-6-Profile

UID: IMP/IVD/2020/000084_ffd8b33f69c12662765d250428535aa2_c1bb7940a407fe0d72db56b2d85d6eef

Brand Name

Orgentec

License Holder

Weldon Biotech India Pvt. Ltd

Device Class

Class B

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

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ENA-6-Profile

Brand: Anti-Gliadin IgG

Sebia Diagnostics India Pvt. Ltd.

ENA-6-Profile - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

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ENA-6-Profile

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