Metabolic Panel - India CDSCO Medical Device Registration

Metabolic Panel is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/001079_8616912ae115c0c9c2ab7e46ecadb59d_70ea71389095befe94ccdd7729dadbac. 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

Metabolic Panel

UID: IMP/IVD/2020/001079_8616912ae115c0c9c2ab7e46ecadb59d_70ea71389095befe94ccdd7729dadbac

Brand Name

Skyla

License Holder

Kin Diagnostics

Device Class

Class B

Approving Authority

CDSCO

Product Information

The skyla Metabolic Panel used with skyla Clinical Chemistry Analyzer, is intended to be used for the quantitative determination of Albumin (Skyla), Alanine Aminotransferase (Skyla), Aspartate Aminotransferase (Skyla), Blood Urea Nitrogen (Skyla), Calcium (Skyla), Chloride (Skyla), Creatinine (Skyla), Blood Glucose (Skyla), Phosphorus (Skyla), Potassium (Skyla), Sodium (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 Globulin (Skyla) can then be obtained