Duo Dengue Ag-IgG/IgM Rapid Test - India CDSCO Medical Device Registration

Duo Dengue Ag-IgG/IgM Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000046_b74cc1ba206f1711419c482e8e05859a_c21506da41a071f5e148109be85c59f0. 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 C. The approving authority is Central Drug Standard Control Organisation, South Zone.

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CDSCO Registered

Class Class C

Duo Dengue Ag-IgG/IgM Rapid Test

UID: MFG/IVD/2020/000046_b74cc1ba206f1711419c482e8e05859a_c21506da41a071f5e148109be85c59f0

Brand Name

TRUSTline

License Holder

Athenese-Dx Private Limited

Device Class

Class C

Approving Authority

Central Drug Standard Control Organisation, South Zone

Product Information

The TRUSTline Dengue Ag-IgG/IgM Rapid Test is a single use lateral flow immunoassay rapid test intended for qualitative detection and differentiation of anti-dengue virus IgG, IgM and dengue NS1 antigen (TRUSTline) in human serum, plasma or whole blood. The TRUSTline Dengue Ag-IgG/IgM Rapid Test is intended for use as an aid in diagnosis of infection with dengue virus. Any use or interpretation of this preliminary test result must also rely on other clinical findings and the professional judgment of health care providers. Alternative test method(TRUSTline) should be considered to confirm the test result obtained by this device

Class D

Malaria Pf/Pan Ag Rapid Test

Brand: TRUSTline

Athenese-Dx Private Limited

Class D

Brand: TRUSTline

Class D