HBsAg Rapid Test - India CDSCO Medical Device Registration

HBsAg Rapid Test is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000046_d48047f9578cff055c32f1e8aca0818e_0604fc04563106dea010bef2ff7e83bf. 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 D. The approving authority is Central Drug Standard Control Organisation, South Zone.

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CDSCO Registered

Class Class D

HBsAg Rapid Test

UID: MFG/IVD/2020/000046_d48047f9578cff055c32f1e8aca0818e_0604fc04563106dea010bef2ff7e83bf

Brand Name

TRUSTline

License Holder

Athenese-Dx Private Limited

Device Class

Class D

Approving Authority

Central Drug Standard Control Organisation, South Zone

Product Information

The TRUSTline HBsAg Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of hepatitis B surface antigen (TRUSTline) in human serum or plasma at level equal to or higher than 0.5 ng/ml. It is intended to be used by healthcare professionals as a screening test and as an aid in the diagnosis of infection with HBsAg. The test kit is not automated and does not require any additional instrument. Any reactive specimen with the TRUSTline HBsAg Rapid Test must be confirmed with alternative testing method(TRUSTline) and clinical findings

Brand: TRUSTline

Athenese-Dx Private Limited

Class C

Brand: TRUSTline

Class D