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Rapid Test for Troponin-I (AMICHECK TROP-I WB ) - India CDSCO Medical Device Registration

Rapid Test for Troponin-I (AMICHECK TROP-I WB ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000043_90d9e092fe55174b769350caf55bfcd4_2df7f47c9b55585d42ddb3dc00da15fb. This device is marketed under the brand name CA 15-3. The license holder is ZEPHYR BIOMEDICALS A DIVISION OF TULIP DIAGNOSTICS PRIVATE LIMITED, and it is classified as Device Class Class C. The approving authority is Sub Zonal Goa.

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CDSCO Registered
Class Class C
Rapid Test for Troponin-I (AMICHECK TROP-I WB )
UID: MFG/IVD/2020/000043_90d9e092fe55174b769350caf55bfcd4_2df7f47c9b55585d42ddb3dc00da15fb

Brand Name

CA 15-3

Device Class

Class C

Approving Authority

Sub Zonal Goa

Product Information

Amicheck-Trop I-WB is a rapid, two-site sandwich immunoassay for the detection of human cardiac Troponin I (CA 15-3)levels in human whole blood, serum and plasma

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