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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_c5c088eea3b5a2af040385d729859b20. 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_c5c088eea3b5a2af040385d729859b20

Brand Name

Semi automated

Device Class

Class A

Approving Authority

Tamil Nadu

Product Information

Blood Cell counter analyzer of 3- 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 the 4 parameters are measuring by the analyzers and rest all parameters like HCT, MCV, MCH, MCHC, NEUT%#, LYMPH%#, MONO%# and others are calculated parameters based on 4 measuring parameters by electro-impedance, optical scattering or dye binding from Human whole blood sample or Body fluids which collected in K2 or K3 EDTA anticoagulant

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