Vietnam MOH registration 240001829/PCBB-HCM

Quantitative K+ Test Electrode

VN: Điện cực xét nghiệm định lượng K+

Vietnam·Risk Class TTBYT Loại B·Potassium Electrode·Roche Diagnostics International Ltd·Registered Aug 16, 2024

Registration details

Analysis ID: 240001829/PCBB-HCM
Submission ID: 000.00.19.H29-240814-0004
Product Type: Potassium Electrode
Product Code: 03111628180

Company information

Manufacturer: Roche Diagnostics International Ltd
Authorized Representative: CÔNG TY TNHH ROCHE VIỆT NAM

Technical details

Intended Use: The K+ electrode is used with the cobas b 221 <4> and <6> configurations in the local test environment to determine the concentration of K+ in whole blood, serum, plasma, and in solutions containing acetate and bicarbonate, and in liquid test material. Additionally, the electrode contributes to the determination of Hematocrit (Hct) by the measurement of conductivity in whole blood and liquid test material, such as quality control test material

Dates and status

Registration Date: Aug 16, 2024

About this record

Access comprehensive regulatory information for Quantitative K+ Test Electrode in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 240001829/PCBB-HCM and manufactured by Roche Diagnostics International Ltd. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.

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