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Automatic Chemiluminescence Immunoassay Analyzer - India CDSCO Medical Device Registration

Automatic Chemiluminescence Immunoassay Analyzer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000171_e833cfa546e41e2bc1aa46c04c195177_add13ae06420e5b231c1b5cd77d90b6d. This device is marketed under the brand name Tisenc. The license holder is Star Biomed Pvt. Ltd., and it is classified as Device Class Class A. The approving authority is CDSCO.

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CDSCO Registered
Class Class A
Automatic Chemiluminescence Immunoassay Analyzer
UID: IMP/IVD/2023/000171_e833cfa546e41e2bc1aa46c04c195177_add13ae06420e5b231c1b5cd77d90b6d

Brand Name

Tisenc

License Holder

Star Biomed Pvt. Ltd.

Device Class

Class A

Approving Authority

CDSCO

Product Information

The Automatic Chemiluminescence Immunoassay Analyzer is an automated in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of concentrations of various analyte in human body fluids. The specific sample type is subject to the instructions for use of Chemiluminescence Immunoassay test reagents that used along with and manufactured by Shenzhen Tisenc Medical Devices Co

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DJ Fang

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