HIT-IgG (PF4-H) Qualitative Antibody Test - Vietnam Registration 220002956/PCBB-BYT
Access comprehensive regulatory information for HIT-IgG (PF4-H) Qualitative Antibody Test in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loแบกi B medical device is registered under number 220002956/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.
Device Details
Registration Details
220002956/PCBB-BYT
000.00.04.G18-220907-0030
HemosIL AcuStar HIT-IgG (PF4-H)
0009802028
Technical Details
HemosIL AcuStar HIT-IgG(PF4-H) is used for the fully automated fluorescent immunoassay, aimed at detecting antibodies IgG reacting with the platelet factor 4 (PF4) (in complex with heparin) in human plasma and blood serum (citrate-anticoagulated), performed on the ACL AcuStar hemostasis analyzer. Antibodies related to heparin are often observed in patients with heparin-induced thrombocytopenia (HIT).
Dates and Status
Sep 07, 2022