Qualitative antibody test for hepatitis C virus
Vietnam·Risk Class TTBYT Loại D·OnSite HCV Ab Plus Rapid Test·Beijing Genesee Biotech, Inc.·Registered Oct 19, 2023- Analysis ID
- 2301331ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-230615-0011
- Product Type
- OnSite HCV Ab Plus Rapid Test
- Product Code
- R0023S
- Manufacturer
- Beijing Genesee Biotech, Inc.
- Manufacturer Country
- CHINA
- Intended Use
- The OnSite HCV Ab Plus Rapid Test is a chromatographic immunoassay based on the principle of unidirectional flow, qualitatively detecting antibodies (IgG, IgM, IgA) against the hepatitis C virus (HCV) in the serum or plasma of humans. The test is intended to be used by healthcare professionals to aid in the diagnosis of HCV infection. Any use or interpretation of the results from this preliminary test must be based on clinical manifestations and the professional judgment of the physician. Other testing methods must be used to confirm the results obtained from this test kit.
- Registration Date
- Oct 19, 2023
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