IVD Department for Quantitative RF Testing
Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Theo theo phụ lục·Registered Nov 23, 2023- Analysis ID
- 230003102/PCBB-HN
- Submission ID
- 000.00.19.H26-231116-0028
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Theo theo phụ lục
- Manufacturer Country
- Theo theo phụ lục
- Intended Use
- - RF Quantitative Test Reagent: A reagent used in in vitro diagnostic tests to automatically quantify the concentration of Rheumatoid Factor (RF) in the blood serum samples of patients. The product is packaged for use with the Beckman Coulter AU biochemical flow analysis machine. - RF Quantitative Test Calibration Standard: A calibration standard used to establish reference curves for determining the quantitative levels of RF tests using the Medicon reagent. - For in vitro diagnostic use by trained laboratory specialists only.
- Registration Date
- Nov 23, 2023
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