Quantitative blood gas analysis (PO2, PCO2), electrolytes (Na+, K+, Ca2+, Cl–), hematocrit, glucose metabolites, and pH measurement
Vietnam·Risk Class TTBYT Loại C·cobas b 123 Sensor Cartridge BG/ISE/Glu·Roche Diagnostics International Ltd·Registered Jul 22, 2024- Analysis ID
- 2401107ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-231013-0009
- Product Type
- cobas b 123 Sensor Cartridge BG/ISE/Glu
- Product Code
- 05331781001
- Manufacturer
- Roche Diagnostics International Ltd
- Manufacturer Country
- SWITZERLAND
- Authorized Representative
- CÔNG TY TNHH ROCHE VIỆT NAM
- Intended Use
- 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.
- Registration Date
- Jul 22, 2024
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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