Quantitative blood gas analysis (PO2, PCO2), electrolytes (Na+, K+, Ca2+, Cl–), hematocrit, glucose metabolites, and pH measurement - Vietnam Registration 2401107ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Quantitative blood gas analysis (PO2, PCO2), electrolytes (Na+, K+, Ca2+, Cl–), hematocrit, glucose metabolites, and pH measurement 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 2401107ĐKLH/BYT-HTTB and manufactured by Roche Diagnostics International Ltd. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.
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Device Details
Registration Details
2401107ĐKLH/BYT-HTTB
000.00.04.G18-231013-0009
cobas b 123 Sensor Cartridge BG/ISE/Glu
05331781001
Technical Details
cobasb123 SensorCartridgeBG/ISE/Glu is designed to be used in the near-patient testing environment with any cobasb123 configuration to measure the quantitative values of pH, the oxygen tension in blood pO2 and pCO2, hematocrit, the concentrations of Na+ , K+ , Ca2+ and Cl- and the total glucose in whole blood to aid in diagnosis and monitoring. It is not intended for self-testing.
Dates and Status
Jul 22, 2024