IVD Department Quantitative Insulin Testing - Vietnam Registration 240001099/PCBB-HCM
Access comprehensive regulatory information for IVD Department Quantitative Insulin 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 240001099/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. 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
240001099/PCBB-HCM
000.00.19.H29-240408-0003
Theo theo phụ lục
Theo phụ lục
Technical Details
1/ ACCESS ULTRASENSITIVE INSULIN: It is a fluorescent chemiluminescence immunoassay for the quantitative determination of insulin in human serum and plasma (EDTA). 2/ ACCESS ULTRASENSITIVE INSULIN CALIBRATORS: Used to calibrate the Access ultra-sensitive insulin assay for the quantitative determination of insulin in human serum and plasma (EDTA) by the Access Immunoassay System.
Dates and Status
May 29, 2024