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_4d18a3a58e4d993a6884f9d37c35ae88. 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_4d18a3a58e4d993a6884f9d37c35ae88

Brand Name

Luminex FlexMAP 3D

License Holder

CPC DIAGNOSTICS PVT.LTD

Device Class

Class A

Approving Authority

CDSCO

Product Information

The Luminex® FLEXMAP 3D® system with xPONENT® software version 4.0 SP1 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 intended for use with specific IVD cleared or approved assays citing its use, to measure multiple similar analytes that establish a single indicator to aid in diagnosis

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Multiplex IVD Analyzer

Brand: Luminex FlexMAP 3D

CPC DIAGNOSTICS PVT.LTD

Class A

Class A