Pure Global
CDSCO UID IMP/IVD/2021/000413_783d382717de19fab419470871e3ab28_fc2f26a1ce5a73128092288f528b1f0b

D-Dimer Test

Star Biomed Pvt. Ltd.·Device Class Class C·India CDSCO·Brand: Finecare cTn I/CK-MB/Myo Rapid Quantitative Test
Registration details
UID
IMP/IVD/2021/000413_783d382717de19fab419470871e3ab28_fc2f26a1ce5a73128092288f528b1f0b
Device class
Class C
Brand name
Finecare cTn I/CK-MB/Myo Rapid Quantitative Test
License holder
Star Biomed Pvt. Ltd.
Approving authority
CDSCO
Product information
The Finecare™ cTn I/CK-MB/Myo Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA System (Finecare cTn I/CK-MB/Myo Rapid Quantitative Test) for quantitative determination of cardiac Troponin I (Finecare cTn I/CK-MB/Myo Rapid Quantitative Test), Creatine Kinase-MB and Myoglobin in human whole blood, serum or plasma
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About this record

D-Dimer Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000413_783d382717de19fab419470871e3ab28_fc2f26a1ce5a73128092288f528b1f0b. This device is marketed under the brand name Finecare cTn I/CK-MB/Myo Rapid Quantitative Test. The license holder is Star Biomed Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is CDSCO.

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