Vietnam MOH registration 240002924/PCBB-HN

Immunoreactive trypsin(ogen) (IRT) quantitative test kit

VN: Bộ xét nghiệm định lượng immunoreactive trypsin(ogen) (IRT)

Vietnam·Risk Class TBYT Loại B·GSP Neonatal IRT kit·Wallac Oy·Registered Oct 29, 2024

Registration details

Analysis ID: 240002924/PCBB-HN
Submission ID: 000.00.19.H26-241018-0014
Product Type: GSP Neonatal IRT kit
Product Code: 3306-0010

Company information

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

Technical details

Intended Use: The GSP Neonatal IRT kit is used with the GSP instrument to quantify immunoreactive trypsin(ogen) (IRT) in dried blood spot samples on filter paper, aiding in the screening of cystic fibrosis in newborns.

Dates and status

Registration Date: Oct 29, 2024

About this record

Access comprehensive regulatory information for Immunoreactive trypsin(ogen) (IRT) quantitative test kit in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại B medical device is registered under number 240002924/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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