Dengue Ag Rapid Test - India CDSCO Medical Device Registration

Dengue Ag Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000046_0c1fcac57991ab53277ef360c331ee8a_0d7f259ec56c7536406693d850cac1ad. 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

Dengue Ag Rapid Test

UID: MFG/IVD/2020/000046_0c1fcac57991ab53277ef360c331ee8a_0d7f259ec56c7536406693d850cac1ad

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 Rapid Test is a single use lateral flow immunoassay rapid test intended for qualitative detection of dengue NS1 antigen (TRUSTline) in human serum, plasma or whole blood. The TRUSTline Dengue Ag 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

HCV Ab Rapid Test

Brand: TRUSTline

Athenese-Dx Private Limited

Class D

Brand: TRUSTline

Class D