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Uncut Sheet of STANDARD F TnI FIA - India CDSCO Medical Device Registration

Uncut Sheet of STANDARD F TnI FIA is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/IVD/2021/000025_50883111ef017b3372018b7e4c9a5579_b4f4973acf41b785a8186b7edb8480d3. This device is marketed under the brand name Bulk. The license holder is SD Biosensor Healthcare Private Limited, and it is classified as Device Class Class C. The approving authority is CDSCO.

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CDSCO Registered
Class Class C
Uncut Sheet of STANDARD F TnI FIA
UID: IMP/IVD/2021/000025_50883111ef017b3372018b7e4c9a5579_b4f4973acf41b785a8186b7edb8480d3

Brand Name

Bulk

Device Class

Class C

Approving Authority

CDSCO

Product Information

STANDARD F TnI FIA is a ?uorescence immunoassay for the quantitative determination of total Troponin I (Bulk) levels in human serum and whole blood using STANDARD F Analyzers manufactured by SD BIOSENSOR. This test is an in vitro diagnostic use and intended for use as an aid in the screening and monitoring of acute myocardiac infarction (Bulk)

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