Diatro•Lyse-DIFF - India CDSCO Medical Device Registration

Diatro•Lyse-DIFF is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000512_81cf47f3817f3dbcfb8ff51849899fe1_8edb7f6f707c97143647ac81ea765ccf. 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-DIFF

UID: IMP/IVD/2022/000512_81cf47f3817f3dbcfb8ff51849899fe1_8edb7f6f707c97143647ac81ea765ccf

Brand Name

Diatro•Hypoclean CC

License Holder

M/s SPARK SCIENTIFIC PRIVATE LIMITED

Device Class

Class B

Approving Authority

CDSCO

Product Information

Diatro•Lyse-DIFF lysing reagent is a stabilized and microfiltered lysing agent for stromatolysis of erythtrocytes (Diatro•Hypoclean CC), for quantitative determination of leukocytes (Diatro•Hypoclean CC), leukocyte three-part differentiation (Diatro•Hypoclean CC) and hemoglobin (Diatro•Hypoclean CC) concentration measurement in human blood on on all WBC-3-part Diatron hematology analyzers