Basic Biochemistry Panel - India CDSCO Medical Device Registration

Basic Biochemistry Panel is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/001079_2e0731824c2e8ace7b143fd0a4754e45_a57297abf5c2defafa6cf7b791387f88. This device is marketed under the brand name Skyla. The license holder is Kin Diagnostics, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Basic Biochemistry Panel

UID: IMP/IVD/2020/001079_2e0731824c2e8ace7b143fd0a4754e45_a57297abf5c2defafa6cf7b791387f88

Brand Name

Skyla

License Holder

Kin Diagnostics

Device Class

Class B

Approving Authority

CDSCO

Product Information

The skyla Basic Biochemistry Panel used with skyla Clinical Chemistry Analyzer, is intended to be used for the quantitative determination of Albumin (Skyla), Alanine Aminotransferase (Skyla), Blood Urea Nitrogen (Skyla), Creatinine (Skyla), Blood Glucose (Skyla), Total Protein (Skyla), Uric Acid (Skyla) in human whole blood, plasma, or serum. The calculated values of Albumin/Globulin Ratio (Skyla), Estimated Glomerular Filtration Rate (Skyla), and c Globulin (Skyla) can then be obtained