CDSCO UID IMP/IVD/2023/000037_4cbee8a38bf9dbb423c3804a9cfc07ab_ea156f5020ff5b29526588bfb92a0bd3
Sheath Fluid
Sysmex India Private Limited·Device Class Class B·India CDSCO
Registration details
- UID
- IMP/IVD/2023/000037_4cbee8a38bf9dbb423c3804a9cfc07ab_ea156f5020ff5b29526588bfb92a0bd3
- Device class
- Class B
- License holder
- Sysmex India Private Limited
- 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.
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About this record
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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