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_d24c610270dfc3cba041f9cf239ab2cf. 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_d24c610270dfc3cba041f9cf239ab2cf

Brand Name

EIGHTCHECK-3WP-H

License Holder

Sysmex India Pvt. Ltd.

Device Class

Class B

Approving Authority

CDSCO

Product Information

EIGHTCHECK-3WP-L, are hematology control materials primarily for intralaboratory quality control of automated, semiautomated and manual procedures that measure components of blood. Additionally, EIGHTCHECK-3WP-L, can be used in external quality assessment. Do not use EIGHTCHECK-3WP-L, to calibrate the instrument!

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Brand: H Solution

Class A