Automated ECL Immunoassay Analyzer - India CDSCO Medical Device Registration
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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Brand Name
Electrochemiluminescence immunoassay
License Holder
PSR Diagnostic Pvt LtdDevice Class
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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