Auto Hematology Analyzer - India CDSCO Medical Device Registration

Auto Hematology Analyzer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000522_962b65aebbadf7bd660c523488c6dd5a_0d347da0f7b33d9b5cfcdd015497f3aa. This device is marketed under the brand name ACCUSURE MGHA03+. The license holder is Microgene Diagnostic Systems (p) Ltd, and it is classified as Device Class Class A. The approving authority is CDSCO.

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CDSCO Registered

Class Class A

Auto Hematology Analyzer

UID: IMP/IVD/2022/000522_962b65aebbadf7bd660c523488c6dd5a_0d347da0f7b33d9b5cfcdd015497f3aa

Brand Name

ACCUSURE MGHA03+

License Holder

Microgene Diagnostic Systems (p) Ltd

Device Class

Class A

Approving Authority

CDSCO

Product Information

The device that quantifies the formed elements in blood i.e., erythrocytes, leukocytes and platelets using the principle of electrical impedance. This product is provided for qualified medical staff in hospital to detect the parameters of WBC, RBC, PLT, HGB, etc.in whole blood and Capillary WB, as well as WBC 3-part differential analysis and WBC counting