Automatic Hematology Analyzer - India CDSCO Medical Device Registration

Automatic Hematology Analyzer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000357_ea0b4e8904531511a3f9e8725d6f51a0_0844ded612426116e3a3cd338b27aae6. This device is marketed under the brand name Dirui. The license holder is Genworks Health Private Limited, and it is classified as Device Class Class A. The approving authority is CDSCO.

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CDSCO Registered

Class Class A

Automatic Hematology Analyzer

UID: IMP/IVD/2022/000357_ea0b4e8904531511a3f9e8725d6f51a0_0844ded612426116e3a3cd338b27aae6

Brand Name

Dirui

License Holder

Genworks Health Private Limited

Device Class

Class A

Approving Authority

CDSCO

Product Information

It counts the number of red blood cells and platelets in blood sample with impedance method, test the hemoglobin concentration with colorimetric method, get the total number & have 5-classification of the white blood cells with semi-conductor laser flow cytometry.