Vietnam MOH registration 240000057/PCBB-BYT

HDL-cholesterol and LDL-cholesterol quantitative testing control material

VN: Vật liệu kiểm soát xét nghiệm định lượng HDL-cholesterol và LDL-cholesterol

Vietnam·Risk Class TTBYT Loại B·Lipotrol HDL/LDL Abnormal·Thermo Fisher Scientific Oy·Registered Apr 15, 2024

Registration details

Analysis ID: 240000057/PCBB-BYT
Submission ID: 000.00.04.G18-240412-0002
Product Type: Lipotrol HDL/LDL Abnormal
Product Code: 981907

Company information

Manufacturer: Thermo Fisher Scientific Oy
Manufacturer Country: Vantaa
Authorized Representative: CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM

Technical details

Intended Use: Lipotrol HDL/LDL Abnormal is a quality control serum used to monitor the accuracy and precision of the HDL-Cholesterol and LDL-Cholesterol tests on the Thermo Scientific™ Indiko™ and Konelab™ instruments according to the determination method of Thermo Fisher Scientific Oy. All references to the Konelab system refer to the T series.

Dates and status

Registration Date: Apr 15, 2024

About this record

Access comprehensive regulatory information for HDL-cholesterol and LDL-cholesterol quantitative testing control material 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 240000057/PCBB-BYT and manufactured by Thermo Fisher Scientific Oy. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM.

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