IVD Enzyme Complex: Gamma-GT, ALT/GPT, AST/GOT - Vietnam Registration 240000945/PCBB-HN
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.
This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.
Device Details
Registration Details
240000945/PCBB-HN
000.00.19.H26-240419-0001
Theo theo phụ lục
Theo phụ lục
Technical Details
(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
Apr 26, 2024