pH Quantitative Test Card, pCO2, pO2, Na (Sodium), K (Potassium), Ca (Calcium), Cl (Chloride), Hematocrit - Vietnam Registration 2400849ĐKLH/BYT-HTTB
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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Device Details
Registration Details
2400849ĐKLH/BYT-HTTB
000.00.04.G18-211110-0007
Theo theo phụ lục
Theo phụ lục
Technical Details
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.
Dates and Status
Jun 24, 2024