Vietnam MOH registration 230003074/PCBB-HN

The IVD Drug Test Electrolyte Cluster: CALCIUM, MAGNESIUM, PHOSPHORUS

VN: Cụm IVD thuốc thử điện giải: CALCIUM, MAGNESIUM, PHOSPHORUS

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Theo theo phụ lục·Registered Nov 21, 2023

Registration details

Analysis ID: 230003074/PCBB-HN
Submission ID: 000.00.19.H26-231114-0041
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: -CALCIUM: A quantitative test used in In Vitro diagnosis to measure the concentration of calcium in the blood plasma, serum, or urine samples of patients. The product is packaged to be used with Beckman Coulter's AU biochemical flow analysis machines. -MAGNESIUM: A quantitative test used in In Vitro diagnosis to measure the concentration of magnesium in the blood plasma, serum, or urine samples of patients. The product is packaged to be used with Beckman Coulter's AU biochemical flow analysis machines. -PHOSPHORUS: A quantitative test used in In Vitro diagnosis to determine the concentration of phosphorus in the blood plasma or urine samples of patients. The product is packaged to be used with Beckman Coulter's AU biochemical flow analysis machines. It is intended for use in In Vitro diagnosis performed by trained laboratory professionals.

Dates and status

Registration Date: Nov 21, 2023

About this record

Access comprehensive regulatory information for The IVD Drug Test Electrolyte Cluster: CALCIUM, MAGNESIUM, PHOSPHORUS 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 230003074/PCBB-HN and manufactured by Theo theo phụ lục.

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