Troponin I Test - India CDSCO Medical Device Registration

Troponin I Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2021/000055_9d7cd2fad7f8f10cfebd195624afe127_59c8947a4b7f60ceed6d5dc51efc7b42. This device is marketed under the brand name RAPHA SERO. The license holder is M/s Rapha Diagnostics PVt. Ltd.,, and it is classified as Device Class Class C. The approving authority is Central Drug Standard Control Organisation, South Zone.

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CDSCO Registered

Class Class C

Troponin I Test

UID: MFG/IVD/2021/000055_9d7cd2fad7f8f10cfebd195624afe127_59c8947a4b7f60ceed6d5dc51efc7b42

Brand Name

RAPHA SERO

License Holder

M/s Rapha Diagnostics PVt. Ltd.,

Device Class

Class C

Approving Authority

Central Drug Standard Control Organisation, South Zone

Product Information

LIFELINE Troponin I Test is a rapid, serological, immuno chromatographic assay for the qualitative detection of human Cardiac Troponin I in serum, plasma or whole blood specimens as an aid in the diagnosis of myocardial infarction. This is an In vitro diagnostic test for professional use only

Class C

Troponin I Test

Brand: NS-1

Oscar Medicare Pvt. Ltd

Class C

Brand: SECURE

Class B