Quantitative Testing Control Material 14 Electrolyte, Gas Blood and Biochemistry - Vietnam Registration 2402227ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Quantitative Testing Control Material 14 Electrolyte, Gas Blood and Biochemistry 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 2402227ĐKLH/BYT-HTTB and manufactured by Bionostics Inc. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.
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Device Details
Registration Details
2402227ĐKLH/BYT-HTTB
000.00.04.G18-211007-0019
cobas b 123 AutoQC Pack Tri-Level
05169933001
Technical Details
The cobasb123 AutoQC pack Tri-Level is a multiplexed reference sample intended for use in the near-patient laboratory environment as a control material to monitor the quantitative pH, pCO2 and pO2, SO2, Na+, K+, Ca2+ and Cl-, Hct, tHb and Hb derivatives, as well as glucose, lactate and bilirubin on the cobasb123 POC systems with the AutoQC module (cobasb123 POC <2> and cobasb123 POC <4> systems). It is not intended for self-testing.
Dates and Status
Aug 27, 2024