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High Sensitive Cardiac Troponin I - India CDSCO Medical Device Registration

High Sensitive Cardiac Troponin I is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2023/000171_ae9429f8fb9064f1dfe0d33197a8ebc7_16dfc4e35cbedf55f2a803bae9531e64. This device is marketed under the brand name CLIA. 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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CDSCO Registered
Class Class C
High Sensitive Cardiac Troponin I
UID: IMP/IVD/2023/000171_ae9429f8fb9064f1dfe0d33197a8ebc7_16dfc4e35cbedf55f2a803bae9531e64

Brand Name

CLIA

License Holder

Star Biomed Pvt. Ltd.

Device Class

Class C

Approving Authority

CDSCO

Product Information

High Sensitive Cardiac Troponin I(CLIA) is a chemiluminescence immunoassay test for the quantitative measurement of circulating cardiac troponin I (CLIA) in human serum, plasma and whole blood, which is intended as an aid to diagnosis of myocardial infarction. The detection range of this assay is 0.005ng/mL~50ng/mL

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