CDSCO UID IMP/IVD/2021/000540_fcf9cc966957148fa19398899eb9d946_e8cd9c60c9ca4dbfed8de2adfb816bac

Automated ECL Immunoassay Analyzer

PSR Diagnostic Pvt Ltd·Device Class Class B·India CDSCO·Brand: Electrochemiluminescence immunoassay
Registration details
UID
IMP/IVD/2021/000540_fcf9cc966957148fa19398899eb9d946_e8cd9c60c9ca4dbfed8de2adfb816bac
Device class
Class B
Brand name
Electrochemiluminescence immunoassay
Approving authority
CDSCO
Product information
This product employs the tris (Electrochemiluminescence immunoassay) ruthenium(Electrochemiluminescence immunoassay)-based direct ECL method, and is used in conjunction with matched test reagents; it is clinically intended for qualitative or quantitative testing of analytes in human samples.
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About this record

Automated ECL Immunoassay Analyzer is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000540_fcf9cc966957148fa19398899eb9d946_e8cd9c60c9ca4dbfed8de2adfb816bac. This device is marketed under the brand name Electrochemiluminescence immunoassay. The license holder is PSR Diagnostic Pvt Ltd, and it is classified as Device Class Class B. The approving authority is CDSCO.

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