Chemiluminescence Immunoassay Analyzer(Chemiluminescence Immunoassay Analyzer ) - India CDSCO Medical Device Registration

Chemiluminescence Immunoassay Analyzer(Chemiluminescence Immunoassay Analyzer ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/000040_f17aa3ebfaf5955f75b9a6d81c8cd01d_02171864565bd96adc027ba70e925156. This device is marketed under the brand name U2600 Series. The license holder is BIODX HEALTHCARE, and it is classified as Device Class Class A. The approving authority is CDSCO.

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CDSCO Registered

Class Class A

Chemiluminescence Immunoassay Analyzer(Chemiluminescence Immunoassay Analyzer )

UID: IMP/IVD/2020/000040_f17aa3ebfaf5955f75b9a6d81c8cd01d_02171864565bd96adc027ba70e925156

Brand Name

U2600 Series

License Holder

BIODX HEALTHCARE

Device Class

Class A

Approving Authority

CDSCO

Product Information

Chemiluminescence Immunoassay Analyzer is an automated in vitro diagnostic instrument based on indirect chemiluminescent technology, intended for quantitative detection of analytes in clinical specimens

DJ Fang

MedTech Regulatory Expert

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