IVD Department, Quantitative Pepsinogen II Test
Vietnam·Risk Class TBYT Loại B·Theo theo phụ lục·Abbott GmbH·Registered Oct 02, 2024- Analysis ID
- 240002605/PCBB-HN
- Submission ID
- 000.00.19.H26-240910-0013
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Abbott GmbH
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Abbott GmbH
- Authorized Representative
- VĂN PHÒNG ĐẠI DIỆN ABBOTT LABORATORIES GMBH TẠI THÀNH PHỐ HÀ NỘI
- Intended Use
- Alinity i Pepsinogen II Calibrators are used to calibrate the Alinity i analyzer when performing quantitative analysis of pepsinogen II in human serum and plasma. For more information, refer to the Alinity i Pepsinogen II Calibrators User Manual and the Alinity ci-series Operations Manual. Alinity i Pepsinogen II Controls are used to assess the accuracy of the test and to detect systematic analysis errors of the Alinity i analyzer when performing quantitative analysis of pepsinogen II in human serum and plasma. For more information, refer to the Alinity i Pepsinogen II Controls User Manual and the Alinity ci-series Operations Manual. Alinity i Pepsinogen II (PG II) is a chemiluminescent microparticle immunoassay (CMIA) test used to quantitate pepsinogen II in human serum and plasma on the Alinity i analyzer.
- Registration Date
- Oct 02, 2024
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Access comprehensive regulatory information for IVD Department, Quantitative Pepsinogen II Test 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 240002605/PCBB-HN and manufactured by Abbott GmbH. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN ABBOTT LABORATORIES GMBH TẠI THÀNH PHỐ HÀ NỘI.
This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including Theo theo phụ lục, Abbott GmbH, and 2 recent registrations in the same category. 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.