Vietnam MOH registration 240001181/PCBB-HN

Quantitative D-Dimer Test Kit, Reference Standard

VN: Bộ thuốc thử, chất hiệu chuẩn xét nghiệm định lượng D-Dimer

Vietnam·Risk Class TTBYT Loại B·PATHFAST D-Dimer·LSI Medience Corporation·Registered May 23, 2024

Registration details

Analysis ID: 240001181/PCBB-HN
Submission ID: 000.00.19.H26-240518-0004
Product Type: PATHFAST D-Dimer
Product Code: PF1051-K

Company information

Manufacturer: LSI Medience Corporation
Product Owner: LSI Medience Corporation
Authorized Representative: CÔNG TY TNHH VẠN NIÊN

Technical details

Intended Use: 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

Registration Date: May 23, 2024

About this record

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.