Vietnam MOH registration 240001797/PCBB-HN

HbA1c Quantitative Testing System

VN: Hệ thống xét nghiệm định lượng HbA1c

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·LABNOVATION TECHNOLOGIES, INC·Registered Jul 24, 2024

Registration details

Analysis ID: 240001797/PCBB-HN
Submission ID: 000.00.19.H26-240716-0027
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: LABNOVATION TECHNOLOGIES, INC
Manufacturer Country: Theo theo phụ lục
Product Owner: LABNOVATION TECHNOLOGIES, INC
Authorized Representative: CÔNG TY TNHH XUẤT NHẬP KHẨU THIẾT BỊ Y TẾ T&T VIỆT NAM

Technical details

Intended Use: 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

Registration Date: Jul 24, 2024

About this record

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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