Automated Hematology Analyzer XN-L series XN-350, Automated Hematology Analyzer XN-L series XN-450, Automated Hematology Analyzer XN-L series XN-550 - India CDSCO Medical Device Registration

Automated Hematology Analyzer XN-L series XN-350, Automated Hematology Analyzer XN-L series XN-450, Automated Hematology Analyzer XN-L series XN-550 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000414_fead29a3290475fc439d9307c515ac1e_c8dd3cb0adc5f39fd64ece3a46ec8d92. 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

Automated Hematology Analyzer XN-L series XN-350, Automated Hematology Analyzer XN-L series XN-450, Automated Hematology Analyzer XN-L series XN-550

UID: IMP/IVD/2022/000414_fead29a3290475fc439d9307c515ac1e_c8dd3cb0adc5f39fd64ece3a46ec8d92

License Holder

Sysmex India Private Limited

Device Class

Class A

Approving Authority

CDSCO

Product Information

The XN-L series are automated hematology analyzers for in vitro diagnostic use in clinical laboratories. Only human blood, human body fluids or control blood should be run. Any other use is regarded as non-specified. Use only the reagents and cleaning fluids indicated in this manual. If the instrument fails to function properly as a result of either the user's operation not specified in the manual or the user's utilization of a program not specified by Sysmex, the product warranty does not apply.