Hematology analyzer
- UID
- IMP/IVD/2023/000304_7df8fb1e620622aea6c9f011daf86afe_5ff37853b52b04032cf40ced641cb057
- Device class
- Class A
- Brand name
- Pentra
- License holder
- HORIBA India Pvt. Ltd.
- Approving authority
- CDSCO
- Product information
- The Yumizen H500 OT is a quantitative multiparameters fully automated ematology analyzer used for in vitro diagnostic testing of anticoagulated whole blood specimens. It is used for screening a physiological state (Pentra) or a pathological state of patient populations found in clinical laboratories. The Yumizen H500 OT classifies and enumerates the following parameters: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT
Hematology analyzer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000304_7df8fb1e620622aea6c9f011daf86afe_5ff37853b52b04032cf40ced641cb057. This device is marketed under the brand name Pentra. The license holder is HORIBA India Pvt. Ltd., and it is classified as Device Class Class A. The approving authority is CDSCO.
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