Vietnam MOH registration 2401123ĐKLH/BYT-HTTB
IVD Department quantitative testing of the placental growth factor
VN: Bộ IVD xét nghiệm định lượng yếu tố tăng trưởng bánh nhau
Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Siemens Healthineers·Registered Jul 22, 2024Registration details
- Analysis ID
- 2401123ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-210114-0006
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
Company information
- Manufacturer
- Siemens Healthineers
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Siemens Healthineers
- Authorized Representative
- CÔNG TY TNHH SIEMENS HEALTHCARE
Technical details
- Intended Use
- 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
- Registration Date
- Jul 22, 2024
About this record
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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