Liver Panel - India CDSCO Medical Device Registration

Liver Panel is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/001079_77a36f1e8ca90d5dbde097e59636db0e_2c37a31c5db3a99b3f9c13d019361fe4. 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

Liver Panel

UID: IMP/IVD/2020/001079_77a36f1e8ca90d5dbde097e59636db0e_2c37a31c5db3a99b3f9c13d019361fe4

Brand Name

Skyla

License Holder

Kin Diagnostics

Device Class

Class B

Approving Authority

CDSCO

Product Information

The skyla Liver Panel used with skyla Clinical Chemistry Analyzer, is intended to be used for the quantitative determination of Albumin (Skyla), Alkaline Phosphatase (Skyla), Alanine Aminotransferase (Skyla), Aspartate Aminotransferase (Skyla), Direct Bilirubin (Skyla), Gamma-Glutamyl Transpeptidace (Skyla), Blood Glucose (Skyla), Total Bilirubin (Skyla), Total Protein (Skyla) in human whole blood, plasma, or serum. The calculated values of Albumin/Globulin Ratio (Skyla), Globulin (Skyla), and Indirect Bilirubin (Skyla) can then be obtained