HBsAg ELISA Kit
- UID
- MFG/IVD/2020/000038_f3f23a888627c4d3ca02f0f5e0c95fd8_d33681a0d1e3d709eb9972f8ed85cd0b
- Device class
- Class D
- Brand name
- TRUSTwell
- License holder
- Athenese-Dx Private Limited
- 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
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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