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CDSCO UID IMP/IVD/2020/001079_470cd0499a1fd5ee3b4ea0e1d980d973_6a28f347e32b5c2d3c970b33db4eb622

Clinical Chemistry Analyzer HB1

Kin Diagnostics·Device Class Class A·India CDSCO·Brand: Skyla
Registration details
UID
IMP/IVD/2020/001079_470cd0499a1fd5ee3b4ea0e1d980d973_6a28f347e32b5c2d3c970b33db4eb622
Device class
Class A
Brand name
Skyla
License holder
Kin Diagnostics
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.
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About this record

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.

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