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iStar-Troponin-I - India CDSCO Medical Device Registration

iStar-Troponin-I is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000501_74122aa3ad08613ce3d1f57d56aa3226_b2c1d59ad092a5c982c115e7e03c0269. This device is marketed under the brand name iStar-Troponin-I. The license holder is Matrix Labs, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered
Class Class C
iStar-Troponin-I
UID: IMP/IVD/2023/000501_74122aa3ad08613ce3d1f57d56aa3226_b2c1d59ad092a5c982c115e7e03c0269

Brand Name

iStar-Troponin-I

License Holder

Matrix Labs

Device Class

Class C

Approving Authority

CDSCO

Product Information

The iStar-Troponin-I assay is a chemiluminescent immunoassay (iStar-Troponin-I) for the in vitro quantitative determination of cardiac troponin-I (iStar-Troponin-I) in human serum and plasma using the iStar Immunoassay Analyzer. The iStar-Troponin-I assay is to be used as an aid in diagnosis of myocardial infarction.,iStar-PCT(iStar-Troponin-I)-The iStar-PCT assay is a chemiluminescent immunoassay (iStar-Troponin-I) for the in vitro quantitative determination of procalcitonin (iStar-Troponin-I) in human serum and plasma using the iStar Immunoassay Analyzer. The iStar-PCT assay is to be used as an aid in diagnosis of bacterial infection-related diseases.,iStar- D-dimer(iStar-Troponin-I)-The iStar-D-dimer aasay is a chemiluminescent immunoassay (iStar-Troponin-I) for the quantitative determination of D-dimer in human plasma (iStar-Troponin-I) collected from individuals suspected of deep venous thrombosis (iStar-Troponin-I) and pulmonary embolism (iStar-Troponin-I) using the automated Chemiluminescence Immunoassay Analyzer. The iStar-D-dimer aasay is to be used by laboratory professionals as an aid in management and monitoring patients with DVT and PE together other clinical methods,iStar- IL-6(iStar-Troponin-I)-The iStar-IL-6 assay is a chemiluminescent immunoassay (iStar-Troponin-I) for the quantitative determination of Interleukin-6 (iStar-Troponin-I) in human serum and plasma collected from individuals suspected of inflammatory diseases using the automated Chemiluminescence Immunoassay Analyzer. The iStar-IL-6 assay is to be used by laboratory professionals as an early marker to aid in management of acuate inflammation in severe and critical patients together with other clinical methods.,iStar -NT-proBNP(iStar-Troponin-I)-The iStar-NT-proBNP assay is a chemiluminescent immunoassay (iStar-Troponin-I) for the in vitro quantitative determination of N-terminal prohormone of brain natriuretic peptide (iStar-Troponin-I) in human serum and plasma using the iStar Immunoassay Analyzer. The iStar-NT-proBNP assay is to be used as an aid in diagnosis of heart failure.

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