Clinical Chemistry Analyzer HB1 - India CDSCO Medical Device Registration
Clinical Chemistry Analyzer HB1 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2020/001079_470cd0499a1fd5ee3b4ea0e1d980d973_6a28f347e32b5c2d3c970b33db4eb622. This device is marketed under the brand name Skyla. The license holder is Kin Diagnostics, and it is classified as Device Class Class A. The approving authority is CDSCO.
This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.
Brand Name
Skyla
License Holder
Kin DiagnosticsDevice Class
Approving Authority
CDSCO
Product Information
The skylaTM Clinical Chemistry Analyzer, together with its exclusive HB1 reagent disc series, offers a quick, easy and accurate method to measure various biochemical markers in whole blood, plasma, or serum. The skylaTM Clinical Chemistry Analyzer is operated in any manner different from those described in this manual, the analyzer may produce no or inaccurate results. If used outside safe design limits, the skylaTM Clinical Chemistry Analyzer may not function as intended and may be hazardous. The skylaTM Clinical Chemistry Analyzer should only be used with skylaTM HB1 series of reagent discs.
General Biochemistry Panel
Brand: Skyla
Kin Diagnostics
ER Panel
Brand: Skyla
Kin Diagnostics
Metabolic Panel
Brand: Skyla
Kin Diagnostics
Liver Panel
Brand: Skyla
Kin Diagnostics
Renal Panel
Brand: Skyla
Kin Diagnostics
Basic Biochemistry Panel
Brand: Skyla
Kin Diagnostics
Lipid Panel
Brand: Skyla
Kin Diagnostics
i
Blood Electrolyte Control solution
Brand: i-Smart 30 PRO
General Biochemistry Panel
Brand: Skyla
ER Panel
Brand: Skyla
Metabolic Panel
Brand: Skyla
Liver Panel
Brand: Skyla
Renal Panel
Brand: Skyla
Basic Biochemistry Panel
Brand: Skyla
Lipid Panel
Brand: Skyla
Test Cartridge
Brand: EDAN