IVD Department Quantitative SHBG Testing - Vietnam Registration 240000945/PCBB-HCM
Access comprehensive regulatory information for IVD Department Quantitative SHBG Testing in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 240000945/PCBB-HCM and manufactured by Beckman Coulter, Inc.. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN BECKMAN COULTER HONG KONG LIMITED TẠI TPHCM.
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
240000945/PCBB-HCM
000.00.19.H29-240321-0005
Theo theo phụ lục
Theo phụ lục
Technical Details
1/ SHBG Quantitative Assay (Type: ACCESS SHBG/ Product Code: A48617): It is a fluorescent chemiluminescence, particle-enhanced immunoassay for the quantitative determination of sex hormone-binding globulin levels in human serum and plasma by the Access Immunoassay Systems. 2/ SHBG Quantitative Assay Calibration Standards (Type: ACCESS SHBG CALIBRATORS/ Product Code: A48618): Used to calibrate the Access SHBG quantitative assay for the quantitative determination of the levels of sex hormone-binding globulin in human serum and plasma by the Access Immunoassay Systems. 3/ SHBG Quantitative Assay Quality Control Material (Type: ACCESS SHBG QC/ Product Code: A48619): Used to monitor the performance of the Access SHBG quantitative assay of the system.
Dates and Status
May 06, 2024