Quantitative D-Dimer Test Kit, Reference Standard - Vietnam Registration 240001181/PCBB-HN
Access comprehensive regulatory information for Quantitative D-Dimer Test Kit, Reference Standard 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 240001181/PCBB-HN and manufactured by LSI Medience Corporation. The authorized representative in Vietnam is CÔNG TY TNHH VẠN NIÊN.
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
240001181/PCBB-HN
000.00.19.H26-240518-0004
PATHFAST D-Dimer
PF1051-K
Technical Details
PATHFAST D-Dimer is a product used in in vitro diagnostic testing with the PATHFAST in vitro diagnostic automated analyzer (IVD) to quantitatively determine D-Dimer in whole blood or plasma. PATHFAST D-Dimer is designed to be used: - as a tool in the diagnosis of processes involving the activation of the coagulation system, including deep vein thrombosis (DVT) and pulmonary embolism (PE), - by laboratory technicians, nurses, or physicians, - in hospitals, including emergency rooms, doctor's offices, and clinical laboratories. PATHFAST D-Dimer is a near-patient testing (NPT) device.
Dates and Status
May 23, 2024