Diatro•Dil-DIFF - India CDSCO Medical Device Registration

Diatro•Dil-DIFF is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000512_2af952e07861e992700bf11374be985a_073e7be43c4b3f4926e4eef1855edbee. 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•Dil-DIFF

UID: IMP/IVD/2022/000512_2af952e07861e992700bf11374be985a_073e7be43c4b3f4926e4eef1855edbee

Brand Name

Diatro•Hypoclean CC

License Holder

M/s SPARK SCIENTIFIC PRIVATE LIMITED

Device Class

Class B

Approving Authority

CDSCO

Product Information

Diatro•Dil-DIFF diluent is a buffered, stabilized and microfiltered electrolyte solution for automated dilution of human blood samples, quantitative and qualitative determination of erythrocytes (Diatro•Hypoclean CC), leukocytes (Diatro•Hypoclean CC) and the leukocyte subpopulations, thrombocytes (Diatro•Hypoclean CC) and measurement of hemoglobin (Diatro•Hypoclean CC) concentration on Diatron hematology analyzers