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

Fully-auto chemiluminescence immunoassay analyzer(Fully-auto chemiluminescence immunoassay analyzer ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000239_0fb6ea0c37e4dc459bee30ce75c04ee3_06c56d93086f5bafae60444bd8362b3c. This device is marketed under the brand name MAGLUMI X3. The license holder is GOODWILL DIAGNOSTICS, 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(Fully-auto chemiluminescence immunoassay analyzer )

UID: IMP/IVD/2023/000239_0fb6ea0c37e4dc459bee30ce75c04ee3_06c56d93086f5bafae60444bd8362b3c

Brand Name

MAGLUMI X3

License Holder

GOODWILL DIAGNOSTICS

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

DJ Fang

MedTech Regulatory Expert

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