Renal Panel - India CDSCO Medical Device Registration

Renal Panel is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/001079_561e98cb2eb97b16c0d0e63471990642_614d3965c4ebd6995e3d75bad94b7e88. 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

Renal Panel

UID: IMP/IVD/2020/001079_561e98cb2eb97b16c0d0e63471990642_614d3965c4ebd6995e3d75bad94b7e88

Brand Name

Skyla

License Holder

Kin Diagnostics

Device Class

Class B

Approving Authority

CDSCO

Product Information

The skyla Renal Panel used with skyla Clinical Chemistry Analyzer, is intended to be used for the quantitative determination of Albumin (Skyla), Blood Urea Nitrogen (Skyla), Calcium (Skyla), Chloride (Skyla), Creatine Phosphokinase (Skyla), Creatinine (Skyla), Blood Glucose (Skyla), Phosphorus (Skyla), Potassium (Skyla), Sodium (Skyla) in human whole blood, plasma, or serum. The calculated values of Estimated Glomerular Filtration Rate (Skyla) can then be obtained