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_ff0ce2b893cfe4edefce6afda6705121. This device is marketed under the brand name Standard LipidoCare Analyzer. The license holder is SD Biosensor Healthcare 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

Analyzer

UID: IMP/IVD/2021/000025_dc45bce0f3f919525f258c2343bcf135_ff0ce2b893cfe4edefce6afda6705121

Brand Name

Standard LipidoCare Analyzer

License Holder

SD Biosensor Healthcare Private Limited

Device Class

Class A

Approving Authority

CDSCO

Product Information

The STANDARD LipidoCare Analyzer is designed to measure the quantitative measurement of the blood parameters: Total Cholesterol(Standard LipidoCare Analyzer), Triglycerides(Standard LipidoCare Analyzer), High-Density Lipoprotein Cholesterol(Standard LipidoCare Analyzer), calculated ‘LDL’, ‘LDL/HDL’, ‘non-HDL’. This system is intended for in vitro diagnostic use to test fresh capillary whole blood, venous whole blood plasma or serum