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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Device Details
Registration Details
230002386/PCBB-HCM
000.00.19.H29-231014-0003
Theo theo phụ lục
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

