Vietnam MOH registration 220002956/PCBB-BYT

HIT-IgG (PF4-H) Qualitative Antibody Test

VN: Thuốc thử xét nghiệm định tính kháng thể HIT-IgG (PF4-H)

Vietnam·Risk Class TTBYT Loại B·HemosIL AcuStar HIT-IgG (PF4-H)·Biokit, S.A.·Registered Sep 07, 2022

Registration details

Analysis ID: 220002956/PCBB-BYT
Submission ID: 000.00.04.G18-220907-0030
Product Type: HemosIL AcuStar HIT-IgG (PF4-H)
Product Code: 0009802028

Company information

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

Technical details

Intended Use: 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

Registration Date: Sep 07, 2022

About this record

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 Loại B medical device is registered under number 220002956/PCBB-BYT and manufactured by Biokit, S.A..

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