HBsAg ELISA Kit - India CDSCO Medical Device Registration

HBsAg ELISA Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000038_f3f23a888627c4d3ca02f0f5e0c95fd8_d33681a0d1e3d709eb9972f8ed85cd0b. This device is marketed under the brand name TRUSTwell. 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 ELISA Kit

UID: MFG/IVD/2020/000038_f3f23a888627c4d3ca02f0f5e0c95fd8_d33681a0d1e3d709eb9972f8ed85cd0b

Brand Name

TRUSTwell

License Holder

Athenese-Dx Private Limited

Device Class

Class D

Approving Authority

Central Drug Standard Control Organisation, South Zone

Product Information

The HBsAg ELISA Kit is a solid phase enzyme linked immunosorbent assay for the qualitative detection of hepatitis B virus surface antigen (TRUSTwell) in human serum or plasma. It is intended for professional use only as an aid in the diagnosis of infection with HBV. Any reactive specimen with the HBsAg ELISA Kit must be confirmed with alternative testing method(TRUSTwell) and clinical findings

Class D

Brand: TRUSTline

Class D