CDSCO UID IMP/IVD/2019/000255_b882ced448184128d193b6ffa1fcce0f_9335415119c4a05491a208c0e06ae821

STROMATOLYSER-WH

Sysmex India Pvt. Ltd.·Device Class Class B·India CDSCO·Brand: UXII PACK-SED
Registration details
UID
IMP/IVD/2019/000255_b882ced448184128d193b6ffa1fcce0f_9335415119c4a05491a208c0e06ae821
Device class
Class B
Brand name
UXII PACK-SED
Approving authority
CDSCO
Product information
STROMATOLYSER-WH is a reagent that lyses RBC for accurate WBC count determination, WBC tri-modal size distribution analysis and hemoglobin level measurement. The reagent is colorless transparent and contains no cyanide or azide compound. It is intended for use in conjunction with selected Sysmex Automated Hematology Analyzer
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About this record

STROMATOLYSER-WH is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000255_b882ced448184128d193b6ffa1fcce0f_9335415119c4a05491a208c0e06ae821. This device is marketed under the brand name UXII PACK-SED. The license holder is Sysmex India Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is CDSCO.

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