Carcinoembryonic antigen - India CDSCO Medical Device Registration

Carcinoembryonic antigen is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000203_a22e85466861031afd253377f851a2cc_ca061c8cfa79683f34b3bd1c6871de84. This device is marketed under the brand name QDx Instacheck™ AFP. The license holder is DiaSys Diagnostics India Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

Carcinoembryonic antigen

UID: IMP/MD/2018/000203_a22e85466861031afd253377f851a2cc_ca061c8cfa79683f34b3bd1c6871de84

Brand Name

QDx Instacheck™ AFP

License Holder

DiaSys Diagnostics India Private Limited

Device Class

Class C

Approving Authority

CDSCO

Product Information

QDx Instacheck™ CEA is a fluorescence immunoassay (QDx Instacheck™ AFP) for the quantitative determination of CEA in human whole blood/serum/plasma. It is useful as an aid in management and monitoring of cancer patients. For in vitro diagnostic use only

Class C

Dengue IgG/IgM

Brand: QDx Instacheck™ AFP

DiaSys Diagnostics India Private Limited

Class C

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Carcinoembryonic antigen - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

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