Vietnam MOH registration 220002957/PCBB-BYT

Drug Test for Quantitative Analysis of Weak Factor von Willebrand

VN: Thuốc thử xét nghiệm định lượng kháng nguyên yếu tố von Willebrand

Vietnam·Risk Class TTBYT Loại B·HemosIL AcuStar VWF:Ag·Biokit, S.A.·Registered Sep 09, 2022

Registration details

Analysis ID: 220002957/PCBB-BYT
Submission ID: 000.00.04.G18-220908-0012
Product Type: HemosIL AcuStar VWF:Ag
Product Code: 0009802020

Company information

Manufacturer: Biokit, S.A.
Manufacturer Country: Spain

Technical details

Intended Use: HemosIL AcuStar von Willebrand Factor Antigen (HemosIL AcuStar VWF:Ag) is a fully automated fluorescent immunoassay test used to quantify the von Willebrand factor antigen in human plasma samples (anticoagulated with citrate), performed on the ACL AcuStar hemostasis analyzer. The HemosIL AcuStar von Willebrand Factor Antigen test is indicated for patients with clinical signs suggestive of von Willebrand disease.

Dates and status

Registration Date: Sep 09, 2022

About this record

Access comprehensive regulatory information for Drug Test for Quantitative Analysis of Weak Factor von Willebrand 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 220002957/PCBB-BYT and manufactured by Biokit, S.A..

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.