Anti-beta-2-Glycoprotein IgG/IgM - India CDSCO Medical Device Registration

Anti-beta-2-Glycoprotein IgG/IgM is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000084_fef96e5e806e64018573d1912d2caca0_ff098593d66b9e085c26586de65d07c4. 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

Anti-beta-2-Glycoprotein IgG/IgM

UID: IMP/IVD/2020/000084_fef96e5e806e64018573d1912d2caca0_ff098593d66b9e085c26586de65d07c4

Brand Name

Orgentec

License Holder

Weldon Biotech India Pvt. Ltd

Device Class

Class B

Approving Authority

CDSCO

Product Information

Anti-beta-2-Glycoprotein I IgG/IgM is an ELISA test system for the quantitative measurement of I IgG and IgM class autoantibodies against beta-2-Glycoprotein I in human serum or plasma. This product is intended for professional in vitro diagnostic use only

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Brand: Orgentec

Weldon Biotech India Pvt. Ltd

Anti-beta-2-Glycoprotein IgG/IgM - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

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