Automated Blood Coagulation Analyzer CS-5100 - India CDSCO Medical Device Registration

Automated Blood Coagulation Analyzer CS-5100 is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2022/000490_9693777a6933f88fd9b9dcae6ff1e725_79eb132e91638c4007d0b8365afff07c. 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-5100

UID: IMP/IVD/2022/000490_9693777a6933f88fd9b9dcae6ff1e725_79eb132e91638c4007d0b8365afff07c

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 only sample for analysis is plasma component of human blood with added anticoagulant ##PLACEHOLDER_0##. However, plasma, serum, or urine samples can be analyzed for FDP analysis. This instrument cannot be used for any other purposes. Only reagents and detergents mentioned in this manual are permitted for use. The specified conditions of use also entail the observance of the cleaning and maintenance procedures described in these instructions