Qualitative HBsAg Test
Vietnam·Risk Class TTBYT Loại D·Bioline™ HBsAg·Abbott Diagnostics Korea Inc.·Registered Jun 20, 2023- Analysis ID
- 2300552ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-210205-0019
- Product Type
- Bioline™ HBsAg
- Product Code
- 01FK10
- Manufacturer
- Abbott Diagnostics Korea Inc.
- Manufacturer Country
- REPUBLIC OF
- Intended Use
- 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.
- Registration Date
- Jun 20, 2023
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