Decontamination Solution - India CDSCO Medical Device Registration

Decontamination Solution is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000129_f1e2e147d3964526cdf1d66d9093627d_21ebd16e5a1522bde4de2299bf20f7f5. 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

Decontamination Solution

UID: IMP/IVD/2019/000129_f1e2e147d3964526cdf1d66d9093627d_21ebd16e5a1522bde4de2299bf20f7f5

License Holder

Sysmex India Private Limited

Device Class

Class B

Approving Authority

CDSCO

Product Information

For In Vitro Diagnostic Use. Decontamination Solution is a solution to clean sample pathways of Sysmex Partec clinical flow cytometers by reducing residual protein. It is ready to use and will be fed to the instrument via sample port manually or via automated loading system. Decontamination Solution is a general laboratory accessory solution and does not provide any diagnostic information. Handling with Decontamination Solution is restricted to lab technicians and trained FCM operators