Flow Cytometer XF-1600 - India CDSCO Medical Device Registration

Flow Cytometer XF-1600 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000490_e918a5c791d1b0688f3aba794397d9a1_1d8fb872fc566805554659aa5d917b1a. 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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CDSCO Registered

Class Class A

Flow Cytometer XF-1600

UID: IMP/IVD/2022/000490_e918a5c791d1b0688f3aba794397d9a1_1d8fb872fc566805554659aa5d917b1a

License Holder

Sysmex India Private Limited

Device Class

Class A

Approving Authority

CDSCO

Product Information

The Sysmex Flow Cytometer XF-1600 is intended for use as an in vitro diagnostic device for immunophenotyping. It is equipped with 10 fluorescence detection channels and two light scatter channels by means of a blue ##PLACEHOLDER_0## laser, a red ##PLACEHOLDER_0## laser, and a violet ##PLACEHOLDER_0## laser. It is to be used by healthcare professionals and properly trained personnel in a laboratory environment. It is intended to be used to analyze human specimens in conjunction with appropriate antibody reagents to generate information that will serve as an aid to diagnosis, monitoring, or prognosis. The Sysmex Flow Cytometer XF-1600 works as an automated analyzer to provide quantitative results. Manual review of the results and visual inspection of the plots is recommended. For appropriate use of the product, refer to the instructions for use of the applicable reagents