Luminex 100/200 System - India CDSCO Medical Device Registration

Luminex 100/200 System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000440_61b0c2935eec0e751d1c4edff72430d0_5665c16d97ae98a9d49bbbd1cd8603b6. The license holder is Thermo Fisher Scientific India 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

Luminex 100/200 System

UID: IMP/IVD/2023/000440_61b0c2935eec0e751d1c4edff72430d0_5665c16d97ae98a9d49bbbd1cd8603b6

License Holder

Thermo Fisher Scientific India Pvt. Ltd.

Device Class

Class A

Approving Authority

CDSCO

Product Information

The Luminex® 200™ instrument is a clinical multiplex test system intended to measure and sort multiple signals generated in an In Vitro Diagnostic assay from a clinical sample. This instrumentation is used with a specific assay to measure multiple similar analytes that establish a single indicator to aid in diagnosis. The device includes a signal reader unit, raw data storage mechanisms, data acquisition software and software to process detected signals