IVD Department qualitative and quantitative β-hCG testing
Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Theo theo phụ lục·Registered Jul 28, 2023- Analysis ID
- 230001771/PCBB-HN
- Submission ID
- 000.00.19.H26-230710-0028
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Theo theo phụ lục
- Manufacturer Country
- Theo theo phụ lục
- Intended Use
- ARCHITECT Total β-hCG Calibrators are used to calibrate the ARCHITECT iSystem when performing qualitative and quantitative analysis of the membrane-bound beta-hCG (β-hCG) in human serum and plasma. ARCHITECT Total β-hCG Controls are used in quality control to monitor the accuracy and precision of the ARCHITECT Total β-hCG test in human serum or plasma samples. ARCHITECT Total β-hCG is a Fluorescence Immunoassay (CMIA) test for the quantitative and qualitative analysis of the membrane-bound beta-hCG (β-hCG) in human serum and plasma to detect early pregnancy.
- Registration Date
- Jul 28, 2023
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Access comprehensive regulatory information for IVD Department qualitative and quantitative β-hCG testing in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 230001771/PCBB-HN and manufactured by Theo theo phụ lục.
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