Qualitative HBsAg Test - Vietnam Registration 2300552ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Qualitative HBsAg Test 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 2300552ĐKLH/BYT-HTTB and manufactured by Abbott Diagnostics Korea Inc..
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Device Details
Registration Details
2300552ĐKLH/BYT-HTTB
000.00.04.G18-210205-0019
Bioline™ HBsAg
01FK10
Technical Details
The Bioline™ HBsAg Test is an in vitro (in-vidro) immunoassay designed to detect the presence of HBsAg in human serum or plasma. The Bioline™ HBsAg Test is intended for professional use as a diagnostic aid. Positive specimens should be confirmed by a supplemental test. The test is intended for in vitro (in-vidro) diagnostic use only. This product is suitable for use in pregnant women, but we have not performed this test on newborns. The test may not be suitable for the diagnosis of early infection or blood donation screening.
Dates and Status
Jun 20, 2023