Qualitative RNA gene fusion test kit for screening of leukemia - Vietnam Registration 240002251/PCBB-HCM
Access comprehensive regulatory information for Qualitative RNA gene fusion test kit for screening of leukemia in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại B medical device is registered under number 240002251/PCBB-HCM and manufactured by EntroGen, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH CÔNG NGHỆ SINH HỌC MBS.
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Device Details
Registration Details
240002251/PCBB-HCM
000.00.19.H29-240930-0010
Leukemia Translocation Panel
LEUKMP-RT24
Technical Details
Leukemia Translocation Panel is a One-Step qualitative detection panel used to detect the fusion E2A/PBX1 (e13/e2), TEL/AML1 (e5/e2), MLL/AF4 (e9/e5), MLL/AF4 (e9/e4), MLL/AF4 (e10/e4), MLL/AF4 (e10/e5), MLL/AF4 (e11/e4), MLL/AF4 (e11/e5), PML/RARa (bcr1), PML/RARa (bcr2), PML/RARa (bcr3), CBFB/MYH11 (A type), CBFB/MYH11 (D type), CBFB/MYH11 (E type), AML1/ETO (e5/e2) in bone marrow or peripheral blood samples.
Dates and Status
Oct 02, 2024