LYSE(Lyse ) - India CDSCO Medical Device Registration
LYSE(Lyse ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000280_624460c775e15528857c924c34401966_b1b44ceee810d835ed7d2d6e82753c67. This device is marketed under the brand name Z5 DN. The license holder is GOSWAMI INC, and it is classified as Device Class Class B. The approving authority is CDSCO.
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Brand Name
Z5 DN
License Holder
GOSWAMI INCDevice Class
Approving Authority
CDSCO
Product Information
It's used to break down red blood cell membrane to release hemoglobin before blood cell analysis. It also could shrink other WBC cells except basophils while keeps the original volume of basophils. The instrument detects hemoglobin concentration, and classifies basophile and count total white blood cell via distinguishing the morphological differences among cell volume and cellular complexity
