Vietnam MOH registration 240000078/PCBB-BYT

IVD Quantitative Analysis System for Electrolytes: Na, K, Cl, Li for Clinical Chemistry Analyzers

VN: Hệ thống IVD xét nghiệm định lượng các chất điện giải: Na, K, Cl, Li dùng cho máy xét nghiệm hóa sinh

Vietnam·Risk Class TBYT Loại B·Theo theo phụ lục·Medica Corporation·Registered Oct 25, 2024

Registration details

Analysis ID: 240000078/PCBB-BYT
Submission ID: 000.00.04.G18-241016-0012
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Medica Corporation
Manufacturer Country: Theo theo phụ lục
Product Owner: Medica Corporation
Authorized Representative: CÔNG TY TNHH THIẾT BỊ NHẬT ANH

Technical details

Intended Use: ISE Module: The ISE Module is used as part of the diagnostic testing system, which includes the biochemical analyzers. The device is capable of measuring lithium, sodium, potassium, and chloride, and it transmits the measurement results to the host computer to be integrated with the results of other reported tests. ISE Module Na+ Electrode: The Na+ electrode is used to measure the concentration of sodium in serum, plasma, or diluted urine samples on the ISE Module. ISE Module K+ Electrode: The K+ electrode is used to measure the concentration of potassium in serum, plasma, or diluted urine samples on the ISE Module. ISE Module Li+ Electrode: The Li+ electrode is used to measure the concentration of lithium in serum or plasma samples on the ISE Module. ISE Module Cl- Electrode: The Cl- electrode is used to measure the concentration of chloride in serum, plasma, or diluted urine samples on the ISE Module. ISE Module Reference Electrode: The ISE Module Reference Electrode is used in the measurement of the concentration of sodium, potassium, chloride, and lithium in serum, plasma, or diluted urine samples. ISE Module Spacer Electrode: The ISE Module Spacer Electrode is a white reference electrode used to replace the corresponding selective ion electrodes on the ISE Module for tests that are not required. It is intended for in-vitro diagnostic use. EasyQC Tri-Level Quality Control Kit: Intended for in vitro diagnostic use. The quality control material is used to establish the performance of the ISE Module. EasyQC Bi-Level Quality Control Kit: Intended for in vitro diagnostic use. The quality control material is used to establish the performance of the ISE Module. ISE Module Urine Diluent: The ISE Module Urine Diluent is used to dilute urine samples prior to analysis. ISE Module Cleaning Solution Kit: The Cleaning Solution Kit is a daily cleaning solution for the ISE Module. It is intended for in-vitro diagnostic use.

Dates and status

Registration Date: Oct 25, 2024

About this record

Access comprehensive regulatory information for IVD Quantitative Analysis System for Electrolytes: Na, K, Cl, Li for Clinical Chemistry Analyzers in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại B medical device is registered under number 240000078/PCBB-BYT and manufactured by Medica Corporation. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ NHẬT ANH.

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