HBsAg Lateral Flow Assay kit in human serum/plasma. - India CDSCO Medical Device Registration

HBsAg Lateral Flow Assay kit in human serum/plasma. is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2020/000053_2b20db1cf092e0d87057bf1b347f07a3_9afdbebbf34033ccee49a8ac6e1a4c7d. This device is marketed under the brand name HBsAg ELISA Kit, Labsystems Diagnostics . The license holder is Trivitron Healthcare Pvt. Ltd, 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 Lateral Flow Assay kit in human serum/plasma.

UID: MFG/IVD/2020/000053_2b20db1cf092e0d87057bf1b347f07a3_9afdbebbf34033ccee49a8ac6e1a4c7d

Brand Name

HBsAg ELISA Kit, Labsystems Diagnostics

License Holder

Trivitron Healthcare Pvt. Ltd

Device Class

Class D

Approving Authority

Central Drug Standard Control Organisation, South Zone

Product Information

BiocardTM HBsAg Rapid Test is a, Immunochromatographic assay for the visual detection of Hepatitis B surface antigen (HBsAg ELISA Kit, Labsystems Diagnostics ) in serum or plasma. It is used as an aid in the diagnosis of Hepatitis B infection. The BIOCARDTM HBsAg Test is based on the principle of sandwich Immunochromatographic assay for determination of HBsAg in serum or plasma. This one step test is very sensitive and only takes 5-20 minutes. Test results can be read visually without any instrument