Vietnam MOH registration 220002951/PCBB-BYT

ADAMTS13 Quantitative Activity Assay

VN: Thuốc thử xét nghiệm định lượng hoạt tính ADAMTS13

Vietnam·Risk Class TTBYT Loại B·HemosIL AcuStar ADAMTS13 Activity·Biokit, S.A.·Registered Sep 07, 2022

Registration details

Analysis ID: 220002951/PCBB-BYT
Submission ID: 000.00.04.G18-220907-0021
Product Type: HemosIL AcuStar ADAMTS13 Activity
Product Code: 0009802048

Company information

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

Technical details

Intended Use: HemosIL AcuStar ADAMTS13 Activity is a fully automated immunochemiluminescence assay (CIA) to quantitate ADAMTS13 activity in human plasma (citrate concentration 3.2% or 3.8%), performed on the ACL AcuStar hemostasis analyzer. The test is performed by a qualified laboratory technician. The test result helps support the diagnosis and monitoring of thrombotic thrombocytopenic purpura (TTP). The result should be interpreted in conjunction with other clinical and subclinical data. The test is intended for use in the population of adult individuals. The test should be used only under the direction of a physician.

Dates and status

Registration Date: Sep 07, 2022

About this record

Access comprehensive regulatory information for ADAMTS13 Quantitative Activity Assay 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 220002951/PCBB-BYT and manufactured by Biokit, S.A..

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