Automated Blood Coagulation Analyzer CS-1600 - India CDSCO Medical Device Registration

Automated Blood Coagulation Analyzer CS-1600 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000490_60e27c0a46e9c3a3f5af199d196b61e5_3496101082e2d5e696825b2ea72e684a. 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 Blood Coagulation Analyzer CS-1600

UID: IMP/IVD/2022/000490_60e27c0a46e9c3a3f5af199d196b61e5_3496101082e2d5e696825b2ea72e684a

License Holder

Sysmex India Private Limited

Device Class

Class A

Approving Authority

CDSCO

Product Information

The instrument is an analyzer solely intended for in-vitro diagnosis. The primary sample for analysis is the plasma component of human blood with added anti-coagulant ##PLACEHOLDER_0##. However, for FDP analysis, plasma, serum, and urine can be analyzed. This instrument cannot be used for any other purposes. Only the reagents and detergents mentioned in this manual can be used. The cleaning and maintenance procedures described in this manual should also be adhered to