Hematology analyzer - India CDSCO Medical Device Registration

Hematology analyzer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000062_7df8fb1e620622aea6c9f011daf86afe_d1c06ab1ef9fc3508367cc121f44dd62. This device is marketed under the brand name Yumizen. The license holder is HORIBA INDIA 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

Hematology analyzer

UID: IMP/MD/2018/000062_7df8fb1e620622aea6c9f011daf86afe_d1c06ab1ef9fc3508367cc121f44dd62

Brand Name

Yumizen

License Holder

HORIBA INDIA Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

The ABX Pentra XL 80 is a quantitative multiparameters fully automated hematology analyzer used for in vitro diagnostic testing of anticoagulated whole blood specimens. It is used for screening a physiological state (Yumizen) or a pathological state of patient populations found in clinical laboratories. The ABX Pentra XL 80 classifies and enumerates the following parameters: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, PDW, PCT, MPV, LYM#, LYM%, MON#, MON%, NEU#, NEU%, EOS#, EOS%, BAS#, BAS%, ALY#, ALY%, LIC#, LIC%

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ABX Leucodiff (ABX Leucodiff )

Brand: Yumizen

HORIBA INDIA Private Limited

Hematology analyzer - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

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