Abnormal antibody screening test, determining the phenotype of red blood cells, sensitive red blood cells, and blood transfusion compatibility
Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Haemokinesis Ltd·Registered Oct 22, 2024- Analysis ID
- 2402894ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-230329-0027
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Haemokinesis Ltd
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Haemokinesis Ltd
- Authorized Representative
- CÔNG TY CỔ PHẦN THIẾT BỊ Y TẾ VIMEC
- Intended Use
- 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.
- Registration Date
- Oct 22, 2024
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.
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.