Diatro•Diff-5P - India CDSCO Medical Device Registration

Diatro•Diff-5P is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000512_4f53684fbb953859d0598f5e63d60559_9387157dd60771c77d0e0b27af31d172. 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•Diff-5P

UID: IMP/IVD/2022/000512_4f53684fbb953859d0598f5e63d60559_9387157dd60771c77d0e0b27af31d172

Brand Name

Diatro•Hypoclean CC

License Holder

M/s SPARK SCIENTIFIC PRIVATE LIMITED

Device Class

Class B

Approving Authority

CDSCO

Product Information

Diatro•Diff-5P WBC differentiation reagent is a stabilized and micro-filtered reagent for quantitative determination of leukocytes (Diatro•Hypoclean CC) and leukocyte 5-part differentiation (Diatro•Hypoclean CC) measurement in human blood on Diatron Abacus 5 hematology analyzers