IVD Department quantitative testing of the placental growth factor - Vietnam Registration 2401123ĐKLH/BYT-HTTB
Access comprehensive regulatory information for IVD Department quantitative testing of the placental growth factor 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 2401123ĐKLH/BYT-HTTB and manufactured by Siemens Healthineers. The authorized representative in Vietnam is CÔNG TY TNHH SIEMENS HEALTHCARE.
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Device Details
Registration Details
2401123ĐKLH/BYT-HTTB
000.00.04.G18-210114-0006
Theo theo phụ lục
Theo phụ lục
Technical Details
ADVIA Centaur PIGF: ADVIA Centaur Placental Growth Factor (PlGF) is an in vitro diagnostic test used to quantify the PlGF in human plasma and serum (K2 EDTA) on the ADVIA Centaur CP, XP and XPT systems. The ADVIA Centaur PlGF test is used in combination with the ADVIA Centaur sFlt-1 test to determine the sFlt-1/PlGF ratio (the PE ratio). The PE ratio is used in the prediction of preterm birth and adverse outcomes in women with signs and symptoms of preeclampsia. - ADVIA Centaur PIGF QC: ADVIA Centaur PlGF Quality Control (PlGF QC) is an in vitro diagnostic test used to monitor the specificity and accuracy of the ADVIA Centaur PlGF test.
Dates and Status
Jul 22, 2024