pH Quantitative Test Card, pCO2, pO2, Na (Sodium), K (Potassium), Ca (Calcium), Cl (Chloride), Hematocrit
Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Radiometer Medical ApS·Registered Jun 24, 2024- Analysis ID
- 2400849ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-211110-0007
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Radiometer Medical ApS
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Radiometer Medical ApS
- Authorized Representative
- CÔNG TY TNHH KỸ THUẬT NAM PHƯƠNG
- Intended Use
- The SC9 Sensor Cassette is an in vitro diagnostic medical device used with the ABL9 and SP9 Solution Pack. ABL9 is a portable, automated blood gas and electrolyte analyzer that measures pH, blood gas, electrolytes, lactate, and hematocrit in whole blood samples. The ABL9 blood gas and electrolyte analyzer is used by trained technicians, nurses, doctors, and clinical laboratories. The product is intended for use in point-of-care or hospital laboratory settings. ABL9 is an in vitro diagnostic medical device and is intended for use in quantitative testing to support clinical decision-making in the diagnosis of various disorders, including metabolic, respiratory, endocrine, hemolytic, cardiovascular, and infectious conditions in the general patient population.
- Registration Date
- Jun 24, 2024
Access comprehensive regulatory information for pH Quantitative Test Card, pCO2, pO2, Na (Sodium), K (Potassium), Ca (Calcium), Cl (Chloride), Hematocrit in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2400849ĐKLH/BYT-HTTB and manufactured by Radiometer Medical ApS. The authorized representative in Vietnam is CÔNG TY TNHH KỸ THUẬT NAM PHƯƠNG.
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