Fully-auto chemiluminescence immunoassay analyzer - India CDSCO Medical Device Registration

Fully-auto chemiluminescence immunoassay analyzer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000019_32122d1d203d3032910a72409ad93791_cd82ac1843773bf0210323e2d052bdf8. This device is marketed under the brand name MAGLUMI X8. The license holder is Abhi Medico Private Limited, and it is classified as Device Class Class A. The approving authority is CDSCO.

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CDSCO Registered

Class Class A

Fully-auto chemiluminescence immunoassay analyzer

UID: IMP/IVD/2023/000019_32122d1d203d3032910a72409ad93791_cd82ac1843773bf0210323e2d052bdf8

Brand Name

MAGLUMI X8

License Holder

Abhi Medico Private Limited

Device Class

Class A

Approving Authority

CDSCO

Product Information

Used in conjunction with adapter reagents for qualitative and/or quantitative analysis of the analytes in the human sample.

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M/s GENWORKS HEALTH PRIVATE LIMITED., ,Survey No.479/1, 479/2, 479/3, 479/4, 480/1, 480/2, PHASE 2, EAST FACING, GROUND FLOOR, SCHOOL ROAD, KATRAMBAKKAM-602109, Sriperumbudur Taluk, Kancheepuram District, Tamil Nadu. ,Kanchipuram Tamil Nadu ,602109 ,India

Class A