Analyzer - India CDSCO Medical Device Registration

Analyzer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000025_dc45bce0f3f919525f258c2343bcf135_6cc49d9d545d36d3d2485b9867864af9. This device is marketed under the brand name Standard G6PD Analyzer. The license holder is SD Biosensor Healthcare Pvt. Ltd, and it is classified as Device Class Class A. The approving authority is CDSCO.

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CDSCO Registered

Class Class A

Analyzer

UID: IMP/IVD/2021/000025_dc45bce0f3f919525f258c2343bcf135_6cc49d9d545d36d3d2485b9867864af9

Brand Name

Standard G6PD Analyzer

License Holder

SD Biosensor Healthcare Pvt. Ltd

Device Class

Class A

Approving Authority

CDSCO

Product Information

The STANDARD G6PD Analyzer is designed to measure the quantitative determination of total-hemoglobin concentration and G6PD enzymatic activity in fresh human whole blood specimen based on reflectometry assays. The analyzer is for in vitro diagnostic use and professional use only