Vietnam MOH registration 240000051/PCBB-BYT

Standardization of the Quantitative HDL-Cholesterol and LDL-Cholesterol Tests

VN: Chất hiệu chuẩn xét nghiệm định lượng HDL-cholesterol và LDL-cholesterol

Vietnam·Risk Class TTBYT Loại B·HDL/LDL Calibrator·Thermo Fisher Scientific Oy·Registered Apr 04, 2024

Registration details

Analysis ID: 240000051/PCBB-BYT
Submission ID: 000.00.04.G18-240404-0001
Product Type: HDL/LDL Calibrator
Product Code: 981657

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: Used for calibrating the HDL-Cholesterol and LDL-Cholesterol tests according to the determination method of Thermo Fisher Scientific Oy on the Thermo Scientific™ Indiko™ and Konelab™ analyzers. Any reference to the Konelab system refers to the T series.

Dates and status

Registration Date: Apr 04, 2024

About this record

Access comprehensive regulatory information for Standardization of the Quantitative HDL-Cholesterol and LDL-Cholesterol Tests 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 240000051/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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