Quantitative AFP Testing Reference Standard Drug Assay Kit - Vietnam Registration 2400881ĐKLH/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 2400881ĐKLH/BYT-HTTB and manufactured by Siemens Healthcare Diagnostics Products Limited. The authorized representative in Vietnam is CÔNG TY TNHH SIEMENS HEALTHCARE.
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Device Details
Registration Details
2400881ĐKLH/BYT-HTTB
17001973/ĐKLH-BYT-TB-CT
IMMULITE/ IMMULITE 1000 AFP (Name on Label: IMMULITE/ IMMULITE 1000 Systems AFP)
10381162/ LKAP1
Technical Details
For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers - quantitative measurement of alpha-fetoprotein (AFP) in one of two situations: (a) repeated measurements 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