CDSCO UID IMP/IVD/2019/000157_b882ced448184128d193b6ffa1fcce0f_6971ad3e50e0293b3dc161effd58d493

STROMATOLYSER-WH

Sysmex India Private Limited·Device Class Class B·India CDSCO·Brand: UFII PACK-SED
Registration details
UID
IMP/IVD/2019/000157_b882ced448184128d193b6ffa1fcce0f_6971ad3e50e0293b3dc161effd58d493
Device class
Class B
Brand name
UFII PACK-SED
Approving authority
CDSCO
Product information
STROMATOLYSER WH is a reagent that lyses RBC for accurate WBC count determination WBC trimodal 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/2019/000157_b882ced448184128d193b6ffa1fcce0f_6971ad3e50e0293b3dc161effd58d493. This device is marketed under the brand name UFII PACK-SED. The license holder is Sysmex India Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

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