Vietnam MOH registration 2402218ĐKLH/BYT-HTTB

pH Quantitative Test Card, pCO2, pO2, cNa+, cK+, cCa2+, cCl-, Hct, cLac

VN: Thẻ xét nghiệm định lượng pH, pCO2, pO2, cNa+, cK+, cCa2+, cCl-, Hct, cLac

Vietnam·Risk Class TTBYT Loại C·ABL80 SC80·Radiometer Medical ApS·Registered Aug 27, 2024

Registration details

Analysis ID: 2402218ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-211123-0024
Product Type: ABL80 SC80
Product Code: 945-813

Company information

Manufacturer: Radiometer Medical ApS
Manufacturer Country: Theo theo phụ lục
Product Owner: Radiometer Medical ApS
Authorized Representative: CÔNG TY TNHH KỸ THUẬT NAM PHƯƠNG

Technical details

Intended Use: The ABL80 SC80 test card is an in vitro diagnostic medical device used with the ABL80 and SP80 Solution Pack electrolyte analyzers. ABL80 FLEX is a portable, automated blood gas and electrolyte analyzer that measures pH, blood gas, electrolytes, glucose, lactate, hematocrit (ABL80 FLEX) and oxygen saturation (ABL80 FLEX CO-OX) in whole blood samples. The ABL80 FLEX electrolyte and blood gas analyzer is used by trained technicians, nurses, doctors, and clinicians in clinical laboratories or at the point of care. The ABL80 FLEX and ABL80 FLEX CO-OX are in vitro diagnostic medical devices and are used for quantitative testing to support clinical decision-making in the diagnosis of a variety of disorders related to metabolism, respiration, endocrinology, hematology, cardiology, and infection in the general patient population.

Dates and status

Registration Date: Aug 27, 2024

About this record

Access comprehensive regulatory information for pH Quantitative Test Card, pCO2, pO2, cNa+, cK+, cCa2+, cCl-, Hct, cLac in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2402218ĐKLH/BYT-HTTB and manufactured by Radiometer Medical ApS. The authorized representative in Vietnam is CÔNG TY TNHH KỸ THUẬT NAM PHƯƠNG.

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