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/2023/000037_4cbee8a38bf9dbb423c3804a9cfc07ab_ea156f5020ff5b29526588bfb92a0bd3. 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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CDSCO Registered

Class Class B

Sheath Fluid

UID: IMP/IVD/2023/000037_4cbee8a38bf9dbb423c3804a9cfc07ab_ea156f5020ff5b29526588bfb92a0bd3

License Holder

Sysmex India Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

For In Vitro Diagnostic Use. Sheath Fluid is intended to ensure that the sample, fed to the Sysmex Partec clinical flow cytometer, will run under hydrodynamic focusing. Sample run, and Sheath Fluid consumption will be controlled via FCM software automatically. Sheath Fluid is a general laboratory accessory solution and does not provide any diagnostic information. Handling with Sheath Fluid is restricted to lab technicians and trained FCM operators.