Abnormal antibody screening test, determining the phenotype of red blood cells, sensitive red blood cells, and blood transfusion compatibility - Vietnam Registration 2402894ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Abnormal antibody screening test, determining the phenotype of red blood cells, sensitive red blood cells, and blood transfusion compatibility in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2402894ĐKLH/BYT-HTTB and manufactured by Haemokinesis Ltd. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN THIẾT BỊ Y TẾ VIMEC.
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Device Details
Registration Details
2402894ĐKLH/BYT-HTTB
000.00.04.G18-230329-0027
Theo theo phụ lục
Theo phụ lục
Technical Details
In-vitro diagnostic products are permitted to be used only by qualified personnel. These products are used in the indirect antiglobulin test (IAT) to screen for and identify antibodies and to determine certain red blood cell phenotypes (e.g., Fya, Fyb, Lua, Lub). In addition, these products are used in the direct antiglobulin test (DAT) to detect and determine the characteristics of in-vivo sensitive red blood cells and to perform crossmatching in blood banking.
Dates and Status
Oct 22, 2024