Quantitative AFP Testing Reference Standard Drug Assay Kit - Vietnam Registration 2400880ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Quantitative AFP Testing Reference Standard Drug Assay Kit in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2400880ĐKLH/BYT-HTTB and manufactured by Siemens Healthineers. The authorized representative in Vietnam is CÔNG TY TNHH SIEMENS HEALTHCARE.
This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including Siemens Healthcare Diagnostics Products Limited, and 1 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
2400880ĐKLH/BYT-HTTB
17001984/ĐKLH-BYT-TB-CT
Theo theo phụ lục
Theo phụ lục
Technical Details
For in vitro diagnostic use with the IMMULITE 2000 Analytical Systems - quantitative measurement of alpha-fetoprotein (AFP) in one of two situations: (a) continuous measurement in human serum to support the management of patients with non-seminomatous testicular cancer; or (b) measurements in human serum and amniotic fluid in weeks 15 to 20 of pregnancy - used in combination with ultrasound or amniography - to support the detection of open neural tube defects in the fetus.
Dates and Status
Jun 24, 2024