Fully automated clinical chemistry analyser - India CDSCO Medical Device Registration

Fully automated clinical chemistry analyser is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000458_48aa3fec75b8f161bf55e8ceed60e16b_5201b26583c1afba5f669bae721e9d3f. This device is marketed under the brand name Dirui_CS 1300B. The license holder is DiaSys Diagnostics 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

Fully automated clinical chemistry analyser

UID: IMP/IVD/2021/000458_48aa3fec75b8f161bf55e8ceed60e16b_5201b26583c1afba5f669bae721e9d3f

Brand Name

Dirui_CS 1300B

License Holder

DiaSys Diagnostics India Private Limited

Device Class

Class A

Approving Authority

CDSCO

Product Information

The product is a fully automated instrument for quantitative analysis of chemical components in human samples (Dirui_CS 1300B), which can assist in the diagnosis of normal people and patients with related diseases. The product has no independent measuring function and uses the supporting biochemical reagent kit manufactured by DIRUI to finish testing. The detectable indicators include: liver function, renal function, ion-metabolization, blood sugar, blood fat, myocardium enzymogram, immunity and other items