IVD Department qualitative and quantitative β-hCG testing - Vietnam Registration 240002607/PCBB-HN
Access comprehensive regulatory information for IVD Department qualitative and quantitative β-hCG testing 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 240002607/PCBB-HN. 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, 1 companies making similar products including 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.
Device Details
Registration Details
240002607/PCBB-HN
000.00.19.H26-240910-0015
Theo theo phụ lục
Theo phụ lục
Technical Details
ARCHITECT Total β-hCG Calibrators are used to calibrate the ARCHITECT iSystem when performing qualitative and quantitative analysis of the membrane-bound beta-hCG (β-hCG) in human serum and plasma. Refer to the specific Architect Assay User Manual for more information. ARCHITECT Total β-hCG Controls are used in quality control to monitor the accuracy and precision of the ARCHITECT Total β-hCG test in human serum or plasma samples. Refer to the Architect Total β-hCG Assay User Manual and the Architect System Operation Manual for more information. ARCHITECT Total β-hCG is a Fluorescence Immunoassay (CMIA) test for the quantitative and qualitative analysis of the membrane-bound beta-hCG (β-hCG) in human serum and plasma to detect early pregnancy.
Dates and Status
Oct 02, 2024