Vietnam MOH registration 2400516ĐKLH/BYT-HTTB
Qualitative Antibody Test Kit for Toxoplasma IgM
VN: Bộ xét nghiệm định tính kháng thể IgM kháng toxoplasma
Vietnam·Risk Class TTBYT Loại C·VIDAS® TOXO IgM·BIOMERIEUX SA·Registered Apr 10, 2024Registration details
- Analysis ID
- 2400516ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-220629-0047
- Product Type
- VIDAS® TOXO IgM
- Product Code
- 30202
Company information
- Manufacturer
- BIOMERIEUX SA
- Manufacturer Country
- FRANCE
- Product Owner
- BIOMERIEUX SA
- Authorized Representative
- CÔNG TY TNHH BIOMÉRIEUX VIỆT NAM
Technical details
- Intended Use
- VIDAS TOXO IgM is an automated qualitative test intended for use on VIDAS® devices to detect IgM antibodies against Toxoplasma from human serum (lithium heparin or EDTA anticoagulated) by the ELFA (Enzyme-Linked Fluorescent Assay) technique.
Dates and status
- Registration Date
- Apr 10, 2024
About this record
Access comprehensive regulatory information for Qualitative Antibody Test Kit for Toxoplasma IgM 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 2400516ĐKLH/BYT-HTTB and manufactured by BIOMERIEUX SA. The authorized representative in Vietnam is CÔNG TY TNHH BIOMÉRIEUX VIỆT NAM.
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