Troponin test kits - India CDSCO Medical Device Registration

Troponin test kits is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2018/000005_d4f8c4c2fd8c9bb90e3a23ba7ad81955_0f614c99ef1d09941e20a24520220777. This device is marketed under the brand name STANDARD Q Dengue NS1 Ag Test, ULTRA Dengue NS1 Ag Test. The license holder is SD Biosensor Healthcare Pvt. Ltd, and it is classified as Device Class Class C. The approving authority is Sub Zonal Baddi.

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CDSCO Registered

Class Class C

Troponin test kits

UID: MFG/MD/2018/000005_d4f8c4c2fd8c9bb90e3a23ba7ad81955_0f614c99ef1d09941e20a24520220777

Brand Name

STANDARD Q Dengue NS1 Ag Test, ULTRA Dengue NS1 Ag Test

License Holder

SD Biosensor Healthcare Pvt. Ltd

Device Class

Class C

Approving Authority

Sub Zonal Baddi

Product Information

STANDARD F TnI FIA is a ﬂuorescence immunoassay for the quantitative determination of total Troponin I (STANDARD Q Dengue NS1 Ag Test, ULTRA Dengue NS1 Ag Test) 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 (STANDARD Q Dengue NS1 Ag Test, ULTRA Dengue NS1 Ag Test)

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Dengue virus Antigen Test Kits

Brand: STANDARD Q Dengue NS1 Ag Test, ULTRA Dengue NS1 Ag Test

SD Biosensor Healthcare Pvt. Ltd

Troponin test kits - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

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