Diatro•Lyse-5P with Hardware Key - India CDSCO Medical Device Registration

Diatro•Lyse-5P with Hardware Key is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000512_627fbbfe36c1bd780134e66208bc333d_184c9b92014f430bc80c49fab543e064. This device is marketed under the brand name Diatro•Hypoclean CC. The license holder is M/s SPARK SCIENTIFIC PRIVATE LIMITED, and it is classified as Device Class Class B. The approving authority is CDSCO.

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CDSCO Registered

Class Class B

Diatro•Lyse-5P with Hardware Key

UID: IMP/IVD/2022/000512_627fbbfe36c1bd780134e66208bc333d_184c9b92014f430bc80c49fab543e064

Brand Name

Diatro•Hypoclean CC

License Holder

M/s SPARK SCIENTIFIC PRIVATE LIMITED

Device Class

Class B

Approving Authority

CDSCO

Product Information

Diatro•Lyse-5P lysing reagent is a stabilized and micro-filtered lysing agent for stromatolysis of erythtrocytes (Diatro•Hypoclean CC), for quantitative determination of leukocytes (Diatro•Hypoclean CC), leukocyte 5-part differentiation (Diatro•Hypoclean CC) and hemoglobin (Diatro•Hypoclean CC) concentration measurement in human blood on Diatron Abacus 5 hematology analyzers