Sheath Fluid - India CDSCO Medical Device Registration

Sheath Fluid is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000422_4cbee8a38bf9dbb423c3804a9cfc07ab_9195e729917380cc59761e3554aa507a. This device is marketed under the brand name Sheath Fluid. 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

Sheath Fluid

UID: IMP/IVD/2019/000422_4cbee8a38bf9dbb423c3804a9cfc07ab_9195e729917380cc59761e3554aa507a

Brand Name

Sheath Fluid

License Holder

Sysmex India Pvt. Ltd.

Device Class

Class B

Approving Authority

CDSCO

Product Information

For in vitro diagnostic use only. Sheath fluid is intented to ensure that the sample introduced to th flow cytometer will run under hydrodynamic focusing. Sheath Fluid permits the system to run under controlled conditions with particles passing through the flow cell in single file order.