Vietnam MOH registration 230002386/PCBB-HCM

IVD Electrode Cluster: Sodium (Na) Electrode, Potassium (K) Electrode, Chloride (Cl) Electrode

VN: Cụm IVD Điện cực điện giải: Điện cực Sodium (Na), Điện cực Potassium (K), Điện cực Chloride (Cl)

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Theo theo phụ lục·Registered Nov 01, 2023

Registration details

Analysis ID: 230002386/PCBB-HCM
Submission ID: 000.00.19.H29-231014-0003
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Theo theo phụ lục
Manufacturer Country: Theo theo phụ lục

Technical details

Intended Use: Quantitative sodium test electrode for quantitative analysis in test tubes, determining sodium in serum, plasma and urine. Quantitative potassium test electrode for quantitative analysis in test tubes, determining potassium in serum, plasma and urine. Quantitative chloride test electrode for quantitative analysis in test tubes, determining chloride in serum, plasma and urine. Reference quantitative sodium, potassium, chloride test electrode for quantitative analysis in test tubes, determining sodium, potassium, chloride in serum, plasma and urine. IVD diluent for quantitative analysis of sodium, potassium, chloride is a required product for measuring urine samples, used to dilute urine samples. IVD diluent for quantitative analysis of sodium, potassium, chloride is a required product for diluting urine samples to be used with the test electrode. IVD buffer for processing samples in quantitative analysis of sodium, potassium, chloride, this product is used when operating the ISE module on the biochemical analyzer. Calibration standard for quantitative analysis of sodium, potassium, chloride is used as a two-point calibration standard. IVD reference for quantitative analysis of sodium, potassium, chloride is used to measure the reference electrode potential of the selective ion electrode module. Calibration standard for quantitative analysis of sodium, potassium, chloride is required to be used when operating the ISE module. IVD for cleaning the test electrode for biochemical analysis is required when operating the ISE module on the biochemical analyzer. Quantitative chloride test electrode

Dates and status

Registration Date: Nov 01, 2023

About this record

Access comprehensive regulatory information for IVD Electrode Cluster: Sodium (Na) Electrode, Potassium (K) Electrode, Chloride (Cl) 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 230002386/PCBB-HCM and manufactured by Theo theo phụ lục.

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