Controls - India CDSCO Medical Device Registration

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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CDSCO Registered

Class Class B

Controls

UID: IMP/IVD/2019/000162_24b6472fcfa59cddd3f7bbc326582b5f_7ade7636648873e4ec64b48ea18ab1dc

Brand Name

EIGHTCHECK-3WP-H

License Holder

Sysmex India Pvt. Ltd.

Device Class

Class B

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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Brand: H Solution

Class A