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CDSCO UID IMP/IVD/2019/000162_24b6472fcfa59cddd3f7bbc326582b5f_7ade7636648873e4ec64b48ea18ab1dc

Controls

Sysmex India Pvt. Ltd.·Device Class Class B·India CDSCO·Brand: EIGHTCHECK-3WP-H
Registration details
UID
IMP/IVD/2019/000162_24b6472fcfa59cddd3f7bbc326582b5f_7ade7636648873e4ec64b48ea18ab1dc
Device class
Class B
Brand name
EIGHTCHECK-3WP-H
License holder
Sysmex India Pvt. Ltd.
Approving authority
CDSCO
Product information
XN CHECK is intended to be used as a control for complete blood cell count (EIGHTCHECK-3WP-H), white blood cell dierential, reticulocyte, and nucleated red blood cell (EIGHTCHECK-3WP-H) parameters on Sysmex X series instruments
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About this record

Controls is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000162_24b6472fcfa59cddd3f7bbc326582b5f_7ade7636648873e4ec64b48ea18ab1dc. This device is marketed under the brand name EIGHTCHECK-3WP-H. The license holder is Sysmex India Pvt. Ltd., and it is classified as Device Class Class B. The approving authority is CDSCO.

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