ER Panel - India CDSCO Medical Device Registration

ER Panel is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/001079_c11fc483efed3e05863d373daf63e784_a2d4aaee4a359258ee5afc0e8cb116c7. 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

ER Panel

UID: IMP/IVD/2020/001079_c11fc483efed3e05863d373daf63e784_a2d4aaee4a359258ee5afc0e8cb116c7

Brand Name

Skyla

License Holder

Kin Diagnostics

Device Class

Class B

Approving Authority

CDSCO

Product Information

The skyla ER Panel used with skyla Clinical Chemistry Analyzer, is intended to be used for the quantitative determination of Alanine Aminotransferase (Skyla), Amylase (Skyla), Aspartate Aminotransferase (Skyla), Blood Urea Nitrogen (Skyla), Calcium (Skyla), Chloride (Skyla), Creatine Phosphokinase (Skyla), Creatinine (Skyla), Blood Glucose (Skyla), Lipase (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