Hepatitis B Surface Antigen Test Kit - India CDSCO Medical Device Registration

Hepatitis B Surface Antigen Test Kit is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/IVD/2023/000082_99cc61f36bef7d4e442f026af6e802fa_4a2fbec9d2593614f90fc23ebfe26dd5. This device is marketed under the brand name HCV. The license holder is Recombigen Laboratories Pvt Ltd, and it is classified as Device Class Class D. The approving authority is CDSCO -North Zone, Ghaziabad.

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CDSCO Registered

Class Class D

Hepatitis B Surface Antigen Test Kit

UID: MFG/IVD/2023/000082_99cc61f36bef7d4e442f026af6e802fa_4a2fbec9d2593614f90fc23ebfe26dd5

Brand Name

HCV

License Holder

Recombigen Laboratories Pvt Ltd

Device Class

Class D

Approving Authority

CDSCO -North Zone, Ghaziabad

Product Information

One Step Hepatitis B Surface Antigen (HCV) Test is a rapid and convenient immunochromatographic assay for the qualitative detection of HBsAg in human whole blood, serum or plasma samples at or above a level of 1 ng/ml. It is intended for professional use as an aid in the diagnosis of Hepatitis B virus (HCV) infection. This assay provides only a preliminary result. Clinical expertise and professional judgement should be sought to further evaluate the result of the test.