High-Sensitivity Troponin T STAT eCLIA - India CDSCO Medical Device Registration

High-Sensitivity Troponin T STAT eCLIA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000540_cb400ec012f6b87629a692bfb76e52a8_7b22ffa72049858754f23a93dee07147. This device is marketed under the brand name LIFOTRONIC. The license holder is PSR Diagnostic Pvt Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered

Class Class C

High-Sensitivity Troponin T STAT eCLIA

UID: IMP/IVD/2021/000540_cb400ec012f6b87629a692bfb76e52a8_7b22ffa72049858754f23a93dee07147

Brand Name

LIFOTRONIC

License Holder

PSR Diagnostic Pvt Ltd

Device Class

Class C

Approving Authority

CDSCO

Product Information

Immunoassay for in vitro quantitative determination of cardiac troponin T in human serum and plasma. This assay is intended to auxiliary diagnosis of cardial infarction

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