Vietnam MOH registration 240001828/PCBB-HCM

Calcium 2+ Quantitative Test Electrode

VN: Điện cực xét nghiệm định lượng Ca2+

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

Registration details

Analysis ID: 240001828/PCBB-HCM
Submission ID: 000.00.19.H29-240814-0005
Product Type: Calcium Electrode
Product Code: 03111644180

Company information

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

Technical details

Intended Use: The Ca2+ electrode is used with the cobas b 221 <4> and 6> configurations; in the local test medium to determine the concentration of ionized Ca2+ in the whole blood, plasma, serum, and in the dialysis solution containing acetate and bicarbonate, and in the liquid, e.g., quality control material. Additionally, the electrode contributes to the determination of Hematocrit (Hct) by the measurement of conductivity in the whole blood and the liquid, e.g., quality control material

Dates and status

Registration Date: Aug 16, 2024

About this record

Access comprehensive regulatory information for Calcium 2+ Quantitative 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 240001828/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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