Multiplex IVD Analyzer - India CDSCO Medical Device Registration

Multiplex IVD Analyzer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000024_589f8c9ff4f91786d40cf920d564ed4e_29c7b87f8f807bceb8e009129e8b5188. This device is marketed under the brand name Luminex FlexMAP 3D. The license holder is CPC DIAGNOSTICS 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

Multiplex IVD Analyzer

UID: IMP/IVD/2023/000024_589f8c9ff4f91786d40cf920d564ed4e_29c7b87f8f807bceb8e009129e8b5188

Brand Name

Luminex FlexMAP 3D

License Holder

CPC DIAGNOSTICS 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.

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Multiplex IVD Analyzer

Brand: Luminex FlexMAP 3D

CPC DIAGNOSTICS PVT.LTD

Class A

Class A