Qualitative Test for HBsAg Antigen
Vietnam·Risk Class TTBYT Loại D·OnSite HBsAg Combo Rapid Test·Beijing Genesee Biotech, Inc.·Registered May 10, 2024- Analysis ID
- 2400610ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-230523-0021
- Product Type
- OnSite HBsAg Combo Rapid Test
- Product Code
- R0042C
- Manufacturer
- Beijing Genesee Biotech, Inc.
- Manufacturer Country
- CHINA
- Product Owner
- CTK Biotech, Inc.
- Authorized Representative
- CÔNG TY TNHH AVANTA DIAGNOSTICS
- Intended Use
- The test used to qualitatively detect the presence of the HBsAg antigen in the serum, plasma, or whole blood of humans, aiding in the diagnosis of hepatitis B virus (HBV) infection
- Registration Date
- May 10, 2024
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Access comprehensive regulatory information for Qualitative Test for HBsAg Antigen in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại D medical device is registered under number 2400610ĐKLH/BYT-HTTB and manufactured by Beijing Genesee Biotech, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH AVANTA DIAGNOSTICS.
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