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Blood cell count analyser - - India CDSCO Medical Device Registration

Blood cell count analyser - is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2023/000022_db3dc837cf0d2a1f67e2034a91e8bd24_1f2dc66ae886b047a6bc73b0e2c8c733. This device is marketed under the brand name Semi automated. The license holder is Genuine Biosystem Private Limited, and it is classified as Device Class Class A. The approving authority is Tamil Nadu.

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CDSCO Registered
Class Class A
Blood cell count analyser -
UID: MFG/IVD/2023/000022_db3dc837cf0d2a1f67e2034a91e8bd24_1f2dc66ae886b047a6bc73b0e2c8c733

Brand Name

Semi automated

Device Class

Class A

Approving Authority

Tamil Nadu

Product Information

Blood Cell counter analyzer of 5- part differential is a quantitative multi-parameter automated hematology analyzer intended for Invitro diagnostic use in screening patient populations found in clinical laboratories. The parameters in whole blood: WBC, RBC, HGB, PLT which are primary measuring and secondary measurement with respect to WBC to differentiate into 5 parameters (Semi automated) are measuring by the analyzers and rest all parameters like HCT, MCV, MCH, MCHC, NEUT%#, LYMPH%#, MONO%# and others are calculated parameters measuring parameters by Shealth Flow DC detection method, Flow Cytometry methods using a semi conductor Laser direct-current resistance and the density of the cell interior by changes in radio-frequency resistance from whole blood sample or Body fluids which collected in K2 or K3 EDTA anticoagulant

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