Hypochlorite Solution - India CDSCO Medical Device Registration
Hypochlorite Solution is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2019/000129_e37fb97841ce498df19179387514085e_6bd107ba863f5b201d9b77c161da7276. 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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License Holder
Sysmex India Private LimitedDevice Class
Approving Authority
CDSCO
Product Information
Hypochlorite Solution is intended to clean the sample pathway by reducing possibly remaining blood and/or protein residuals from prior sample measurements in Sysmex Partec clinical flow cytometers. Hypochlorite Solution is ready to use and will be fed to the instrument via sample port manually or via automated loading system. Hypochlorite solution is an accessory solution and does not provide any diagnostic information. Handling with Hypochlorite Solution is restricted to lab technicians and trained FCM operators
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