Quantitative HbA1c Control Testing Material
Vietnam·Risk Class TTBYT Loại B·SDB HbA1c Control·SD Biosensor, Inc.·Registered Aug 25, 2023- Analysis ID
- 230000331/PCBB-BYT
- Submission ID
- 000.00.04.G18-230825-0003
- Product Type
- SDB HbA1c Control
- Product Code
- C-A1C
- Manufacturer
- SD Biosensor, Inc.
- Manufacturer Country
- 28161
- Intended Use
- The SDB HbA1c Control is designed to control the performance of the STANDARD™ A1cCare, Multicare™, or STANDARD™ F systems for HbA1c testing. To maintain the quality of the test, it is recommended to perform at least two levels of control material concentration control at the facility on a regular basis. Quality control testing must be performed in accordance with the specified requirements and standard procedures of each laboratory.
- Registration Date
- Aug 25, 2023
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