CDSCO UID IMP/IVD/2021/000025_50883111ef017b3372018b7e4c9a5579_b4f4973acf41b785a8186b7edb8480d3

Uncut Sheet of STANDARD F TnI FIA

SD Biosensor Healthcare Private Limited·Device Class Class C·India CDSCO·Brand: Bulk
Registration details
UID
IMP/IVD/2021/000025_50883111ef017b3372018b7e4c9a5579_b4f4973acf41b785a8186b7edb8480d3
Device class
Class C
Brand name
Bulk
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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About this record

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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