Vietnam MOH registration 2402227ĐKLH/BYT-HTTB

Quantitative Testing Control Material 14 Electrolyte, Gas Blood and Biochemistry

VN: Vật liệu kiểm soát xét nghiệm định lượng 14 thông số điện giải, khí máu và sinh hóa

Vietnam·Risk Class TTBYT Loại C·cobas b 123 AutoQC Pack Tri-Level·Bionostics Inc·Registered Aug 27, 2024

Registration details

Analysis ID: 2402227ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-211007-0019
Product Type: cobas b 123 AutoQC Pack Tri-Level
Product Code: 05169933001

Company information

Manufacturer: Bionostics Inc
Manufacturer Country: UNITED STATES
Authorized Representative: CÔNG TY TNHH ROCHE VIỆT NAM

Technical details

Intended Use: 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

Registration Date: Aug 27, 2024

About this record

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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