IVD Department, Quantitative Pepsinogen II Test - Vietnam Registration 240002605/PCBB-HN
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.
Device Details
Registration Details
240002605/PCBB-HN
000.00.19.H26-240910-0013
Theo theo phụ lục
Theo phụ lục
Technical Details
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.
Dates and Status
Oct 02, 2024