IVD Department, Quantitative Pepsinogen II Test
Vietnam·Risk Class TBYT Loại B·Theo theo phụ lục·Abbott GmbH·Registered Oct 02, 2024- Analysis ID
- 240002604/PCBB-HN
- Submission ID
- 000.00.19.H26-240910-0012
- 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
- The ARCHITECT Pepsinogen II calibrator is used to calibrate the ARCHITECT iSystem when quantifying pepsinogen II in human serum and plasma. Refer to the ARCHITECT Pepsinogen II Assay Manual and the ARCHITECT System Operation Manual for additional information. The ARCHITECT Pepsinogen II Controls are used to assess the accuracy of the test and to detect systematic analytical deviations of the ARCHITECT iSystem when quantifying pepsinogen II in human serum and plasma. Refer to the ARCHITECT Assay Manual and the ARCHITECT System Operation Manual for additional information. ARCHITECT Pepsinogen II (PG II) is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of pepsinogen II in human serum and plasma.
- 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 240002604/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 Abbott GmbH, Theo theo phụ lục, 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.