ADAMTS13 Quantitative Activity Assay - Vietnam Registration 220002951/PCBB-BYT
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 Loแบกi B medical device is registered under number 220002951/PCBB-BYT and manufactured by Biokit, S.A..
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Device Details
Registration Details
220002951/PCBB-BYT
000.00.04.G18-220907-0021
HemosIL AcuStar ADAMTS13 Activity
0009802048
Technical Details
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
Sep 07, 2022