CDSCO UID IMP/IVD/2019/000157_8d6f74525be560685b3609a84e8770fd_53d6b2e1defe1191347dff2cf76c70a5

CELLPACK DFL

Sysmex India Private Limited·Device Class Class B·India CDSCO·Brand: UFII PACK-SED
Registration details
UID
IMP/IVD/2019/000157_8d6f74525be560685b3609a84e8770fd_53d6b2e1defe1191347dff2cf76c70a5
Device class
Class B
Brand name
UFII PACK-SED
Approving authority
CDSCO
Product information
For in vitro diagnostic use only CELLPACK DFL is a reagent used in combination with Fluorocell RET. After diluting the blood with CELLPACK DFL, Fluorocell RET is used to label blood cell components and thereby analyze red blood cell count, reticulocyte count, reticulocyte rate, platelet count, low fluorescence intensity rate, middle fluorescence intensity rate, high fluorescence intensity rate, and immature reticulocyte fraction count. This reagent is to be used by connecting to an automated hematology analyzer specified by Sysmex
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About this record

CELLPACK DFL is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000157_8d6f74525be560685b3609a84e8770fd_53d6b2e1defe1191347dff2cf76c70a5. This device is marketed under the brand name UFII PACK-SED. The license holder is Sysmex India Private Limited, and it is classified as Device Class Class B. The approving authority is CDSCO.

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