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Tuberculosis Interferon Gamma Release Assay - India CDSCO Medical Device Registration

Tuberculosis Interferon Gamma Release Assay is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000060_126091e08a4fa3cd7536f3f62f099f43_37e2a5eca4c82a180bc32e60121b0829. This device is marketed under the brand name EIA. The license holder is Genomix Molecular Diagnostics Pvt Ltd, and it is classified as Device Class Class B. The approving authority is Telangana.

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CDSCO Registered
Class Class B
Tuberculosis Interferon Gamma Release Assay
UID: MFG/IVD/2020/000060_126091e08a4fa3cd7536f3f62f099f43_37e2a5eca4c82a180bc32e60121b0829

Brand Name

EIA

Device Class

Class B

Approving Authority

Telangana

Product Information

For quantitative detection of Interferon Gamma (EIA) that respond to in-vitro stimulation by M. tuberculosis antigens in whole blood. It is intended for use as an aid in the diagnosis of tuberculosis (EIA) infection

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