Vietnam MOH registration 240000945/PCBB-HN

IVD Enzyme Complex: Gamma-GT, ALT/GPT, AST/GOT

VN: Cụm IVD Enzymes: Gamma-GT, ALT/GPT, AST/GOT

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Registered Apr 26, 2024

Registration details

Analysis ID: 240000945/PCBB-HN
Submission ID: 000.00.19.H26-240419-0001
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

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

Technical details

Intended Use: (1) AST/GOT (IFCC): For in vitro diagnostic use to quantitate the activity of aspartate aminotransferase (L-Aspartate: 2-Oxoglutarate Aminotransferase (AST), EC 2.6.1.1) in human serum and plasma using the automated procedures of the Thermo Scientific™ Indiko™ and Konelab™. All references to the Konelab system refer to the T series. (2) ALT/GPT (IFCC): For in vitro diagnostic use to quantitate the activity of alanine aminotransferase (L-Alanine: 2-Oxoglutarate Aminotransferase (ALT), EC 2.6.1.2) in human serum and plasma on the Thermo Scientific™ Indiko™ and Konelab™. All references to the Konelab system refer to the T series. (3) Gamma-GT (IFCC): For in vitro diagnostic use in the quantitation of the activity of Gamma-GT (γ-Glutamyltransferase (GGT), EC 2.3.2.2) in human serum and plasma on the Thermo Scientific™ Indiko™ and Konelab.

Dates and status

Registration Date: Apr 26, 2024

About this record

Access comprehensive regulatory information for IVD Enzyme Complex: Gamma-GT, ALT/GPT, AST/GOT 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 240000945/PCBB-HN. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM.

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