Vietnam MOH registration 240001748/PCBB-HN

Enzym Galactose and Galactose-1-Phosphate Quantitative Test Kit

VN: Bộ xét nghiệm định lượng enzym galactose và galactose-1-phosphate

Vietnam·Risk Class TTBYT Loại B·Neonatal Total Galactose kit·Wallac Oy·Registered Jul 22, 2024

Registration details

Analysis ID: 240001748/PCBB-HN
Submission ID: 000.00.19.H26-240716-0019
Product Type: Neonatal Total Galactose kit
Product Code: 3029-0010

Company information

Manufacturer: Wallac Oy
Authorized Representative: CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM

Technical details

Intended Use: Used to quantify the total amount of galactose (galactose and galactose-1-phosphate) in dried blood samples, aiding in the screening for galactosemia in newborns.

Dates and status

Registration Date: Jul 22, 2024

About this record

Access comprehensive regulatory information for Enzym Galactose and Galactose-1-Phosphate Quantitative Test Kit 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 240001748/PCBB-HN and manufactured by Wallac Oy. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM.

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