IVD Quantitative D-Dimer Test Kit - Vietnam Registration 240000661/PCBB-HN
Access comprehensive regulatory information for IVD Quantitative D-Dimer 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 240000661/PCBB-HN. The authorized representative in Vietnam is CÔNG TY TNHH VẠN NIÊN.
This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH, Theo theo phụ lục, and 2 recent registrations in the same category. 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
240000661/PCBB-HN
000.00.19.H26-240309-0002
Theo theo phụ lục
Theo phụ lục
Technical Details
D-Dimer FS: A diagnostic test to determine the concentration of D-dimer in blood serum on BioMajesty JCABM6010/C. TruCal D-Dimer: A calibration standard for the DiaSys test to determine the concentration of D-Dimer in vitro on the fluorescence system. TruLab D-Dimer Level 1: A quality control material for the test to monitor the performance of the D-Dimer concentration determination in vitro. TruLab D-Dimer Level 2: A quality control material for the test to monitor the performance of the D-Dimer concentration determination in vitro.
Dates and Status
Mar 28, 2024