Rotolavit II-S - India CDSCO Medical Device Registration
Rotolavit II-S is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000130_a0a8b6a41965c3d5b376265c77230353_8438a58cb2a18d88c735f682bd559e33. The license holder is Sysmex India Private Limited, and it is classified as Device Class Class A. The approving authority is CDSCO.
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License Holder
Sysmex India Private LimitedDevice Class
Approving Authority
CDSCO
Product Information
This device type is used to wash blood or other cell-containing samples to prepare the flow cytometric analysis on a sample preparation system and flow cytometer. The process steps can be individually configured by the user and stored in the device. The configured process steps are processed automatically by the device. A wash-cycle may consist of several processes in which the samples are centrifuged, the supernatant decanted, and then each sample tube is filled with a physiological saline solution and mixed. The device should only be used by trained medical personnel in clinical laboratories and used only for the stated purpose. The life cycle of the device specified by the manufacturer is seven years. The lifetime of some parts of the accessories is divergent and is specified in chapter 12.10 of this manual. Any other use beyond this purpose, as well as non-observance of the intended use ##PLACEHOLDER_0## is considered to be improper use. The company Hettich AG accepts no liability for any damage arising from this
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