Scrub typhus IgG/IgM Rapid Test - India CDSCO Medical Device Registration

Scrub typhus IgG/IgM Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2023/000146_7e4a14199e509b3a7f5cfe39fc8e34d9_5aa236010a9d876e5a841907ffa68250. This device is marketed under the brand name TRUSTline. The license holder is Athenese-Dx Private Limited, and it is classified as Device Class Class B. The approving authority is Tamil Nadu.

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CDSCO Registered

Class Class B

Scrub typhus IgG/IgM Rapid Test

UID: MFG/IVD/2023/000146_7e4a14199e509b3a7f5cfe39fc8e34d9_5aa236010a9d876e5a841907ffa68250

Brand Name

TRUSTline

License Holder

Athenese-Dx Private Limited

Device Class

Class B

Approving Authority

Tamil Nadu

Product Information

The TRUSTline Scrub typhus IgG/IgM Rapid Test is a lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of IgG and IgM antibodies for Orientia tsutsugamushi (TRUSTline) in Human Serum/ Plasma/ Whole blood specimen. This device is intended to be used as a screening test and as an aid in the diagnosis of infection with Scrub typhus. Any reactive specimen with the TRUSTline Scrubtyphus IgG/IgM Rapid Test must be confirmed with alternative testing method(TRUSTline) and clinical findings. As per the Classification of medical devices and in vitro diagnostic medical devices under the provisions of the Medical Devices Rules, 2017; the applied product classified under Class (TRUSTline) List of In Vitro Diagnostics Medical Devices under provisions of sub-rule (TRUSTline) rule 4 of the medical devices rules 2017, under the Category Reagents/Kits for the detection of Antibodies to infectious agents with a risk of limited propagation exemplified as under Other Reagents/ Kits for Scrub Typhus Antibody Test (TRUSTline)

Class D

Malaria Pf/Pan Ag Rapid Test

Brand: TRUSTline

Athenese-Dx Private Limited

Class D

Brand: TRUSTline

Class D