HbA1c Quantitative Testing System - Vietnam Registration 240001797/PCBB-HN
Access comprehensive regulatory information for HbA1c Quantitative Testing System 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 240001797/PCBB-HN and manufactured by LABNOVATION TECHNOLOGIES, INC. The authorized representative in Vietnam is CÔNG TY TNHH XUẤT NHẬP KHẨU THIẾT BỊ Y TẾ T&T VIỆT NAM.
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Device Details
Registration Details
240001797/PCBB-HN
000.00.19.H26-240716-0027
Theo theo phụ lục
Theo phụ lục
Technical Details
The HbA1c testing machine is designed for medical professionals to use at the point of care to measure the concentration of glycated hemoglobin (HbA1c) in the whole blood sample and is used to evaluate the long-term control capability of blood glucose concentration, primarily in people with diabetes. The quantitative HbA1c test kit applies the boronate affinity principle to be used with the HbA1c testing machine to detect the concentration of glycosylated hemoglobin in the whole blood sample of humans, primarily for the diagnosis of diabetes and monitoring blood glucose levels in clinical practice. The HbA1c quantitative test control material can assess the quality of the glycosylated hemoglobin system of the HbA1c testing machine. It is used together with the HbA1c testing machine to determine the percentage (%) and concentration (mmol/mol) of glycosylated hemoglobin in the blood of humans of all ages. It can be used to detect glycosylated hemoglobin in hospital laboratories, professional laboratories, etc., and can also be used directly, or under the direct supervision of trained medical personnel.
Dates and Status
Jul 24, 2024

