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IVD Electrode Cluster: Sodium (Na) Electrode, Potassium (K) Electrode, Chloride (Cl) Electrode - Vietnam Registration 230002386/PCBB-HCM

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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230002386/PCBB-HCM
Registration Details
Vietnam MOH Registration: 230002386/PCBB-HCM
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Device Details

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)
Risk Class TTBYT Loại B

Registration Details

230002386/PCBB-HCM

000.00.19.H29-231014-0003

Theo theo phụ lục

Theo phụ lục

Company Information

Theo theo phụ lục

Technical Details

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

Nov 01, 2023