Access TPO Antibody - India CDSCO Medical Device Registration

Access TPO Antibody is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000053_c9ef8ac37de06ece1fe3f924e6ffc134_f100fca048772b3d2e327f7fa3bd6290. This device is marketed under the brand name Access Intact PTH. The license holder is Beckman Coulter India Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Access TPO Antibody

UID: IMP/IVD/2019/000053_c9ef8ac37de06ece1fe3f924e6ffc134_f100fca048772b3d2e327f7fa3bd6290

Brand Name

Access Intact PTH

License Holder

Beckman Coulter India Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The Access TPO Antibody Calibrators are intended to calibrate the Access TPO Antibody assay for the quantitative determination of thyroperoxidase antibody (Access Intact PTH) levels in human serum and plasma using the Access Immunoassay Systems

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