Lyse - India CDSCO Medical Device Registration
Lyse is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000002_70bfb99c873373ccc58bcc1e63064c79_538305b2dba502d848937174f8ff6e60. This device is marketed under the brand name EDAN HC600. The license holder is Edan Medical India Pvt Ltd, and it is classified as Device Class Class B. The approving authority is CDSCO.
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Brand Name
EDAN HC600
License Holder
Edan Medical India Pvt LtdDevice Class
Approving Authority
CDSCO
Product Information
Lyse is used for lysing erythrocytes, counting and sizing the three main leukocytes subpopulations and quantitative determination hemoglobin in a blood sample in combination Diluent on H30 Hematology Analyzers
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Controls(Controls )
Brand: Control-Level 1, Control-Level 2, Control-Level 3
Diluent
Brand: EDAN HC600
Diluent
Brand: EDAN HC600
Diluent
Brand: EDAN HC600
Diluent
Brand: EDAN HC600
Cleaner
Brand: EDAN HC600
Cleaner
Brand: EDAN HC600
Cleaner
Brand: EDAN HC600
Cleaner
Brand: EDAN HC600
Test Cartridge(Test Cartridge )
Brand: Control-Level 1, Control-Level 2, Control-Level 3