Qualitative Antibody IgM Control Material for Rubella Virus Testing
Vietnam·Risk Class TTBYT Loại C·ARCHITECT Rubella IgM Controls·Abbott Ireland Diagnostics Division·Registered Nov 19, 2024- Analysis ID
- 2403745ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-231208-0058
- Product Type
- ARCHITECT Rubella IgM Controls
- Product Code
- 6C18-13
- Manufacturer
- Abbott Ireland Diagnostics Division
- Manufacturer Country
- IRELAND
- Authorized Representative
- VĂN PHÒNG ĐẠI DIỆN ABBOTT LABORATORIES GMBH TẠI THÀNH PHỐ HÀ NỘI
- Intended Use
- The ARCHITECT Rubella IgM Controls material is used to assess the accuracy of the test and to detect systematic analysis deviation of the ARCHITECT iSystem when performing qualitative detection of Rubella virus IgM antibodies in human serum and plasma. Refer to the ARCHITECT Rubella IgM Assay User Manual and the ARCHITECT System Operations Manual for additional information.
- Registration Date
- Nov 19, 2024
Access comprehensive regulatory information for Qualitative Antibody IgM Control Material for Rubella Virus Testing 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 2403745ĐKLH/BYT-HTTB and manufactured by Abbott Ireland Diagnostics Division. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN ABBOTT LABORATORIES GMBH TẠI THÀNH PHỐ HÀ NỘI.
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