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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/IVD/2023/000304_7df8fb1e620622aea6c9f011daf86afe_7c320792251a1a84b9783a639b985590. 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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CDSCO Registered
Class Class A
Hematology analyzer
UID: IMP/IVD/2023/000304_7df8fb1e620622aea6c9f011daf86afe_7c320792251a1a84b9783a639b985590

Brand Name

Pentra

Device Class

Class A

Approving Authority

CDSCO

Product Information

The Pentra XLR is a quantitative multiparametersfully automated hematology analyzer used for in vitro diagnostic testing of anticoagulated whole blood specimens.It is used for screeningaphysiological state (Pentra) or a pathological state of patient populations found in clinical laboratories. The Pentra XLRclassifies and enumerates the following parameters: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV, PDW, PCT, LYM#, LYM%, MON#, MON%, NEU#, NEU%, EOS#, EOS%, BAS#, BAS%, ALY#, ALY%, LIC#, LIC%, RET#, RET%, RETL, RETM, RETH, CRC, MRV, IRF, RHCc

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