Vietnam MOH registration 240002251/PCBB-HCM
Qualitative RNA gene fusion test kit for screening of leukemia
VN: Bộ xét nghiệm định tính RNA các gen dung hợp để sàng lọc các bệnh bạch cầu
Vietnam·Risk Class TBYT Loại B·Leukemia Translocation Panel·EntroGen, Inc.·Registered Oct 02, 2024Registration details
- Analysis ID
- 240002251/PCBB-HCM
- Submission ID
- 000.00.19.H29-240930-0010
- Product Type
- Leukemia Translocation Panel
- Product Code
- LEUKMP-RT24
Company information
- Manufacturer
- EntroGen, Inc.
- Product Owner
- EntroGen, Inc.
- Authorized Representative
- CÔNG TY TNHH CÔNG NGHỆ SINH HỌC MBS
Technical details
- Intended Use
- 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
- Registration Date
- Oct 02, 2024
About this record
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.
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.
Free DatabasePowered by Pure Global AI300,000+ Devices