IVD Department Quantitative hGH Testing - Vietnam Registration 240001098/PCBB-HCM
Access comprehensive regulatory information for IVD Department Quantitative hGH 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 240001098/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.
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Device Details
Registration Details
240001098/PCBB-HCM
000.00.19.H29-240408-0002
Theo theo phụ lục
Theo phụ lục
Technical Details
1/ ACCESS ULTRASENSITIVE hGH: It is an enzyme-linked immunosorbent assay (ELISA) with chemiluminescence detection, used to quantify the levels of hGH in human serum and plasma by the Access Immunoassay System. 2/ ACCESS ULTRASENSITIVE hGH CALIBRATORS : They are used to calibrate the Access hGH ultra-sensitive assay to quantify the levels of hGH in human serum and plasma by the Access Immunoassay System.
Dates and Status
May 29, 2024