IVD Department quantitative AFP testing
Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Registered Aug 30, 2024- Analysis ID
- 2402490ĐKLH/BYT-HTTB
- Submission ID
- 17002498/ĐKLH-BYT-TB-CT
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Authorized Representative
- CÔNG TY TNHH SIEMENS HEALTHCARE
- Intended Use
- - ADVIA Centaur AFP: It is intended for in vitro diagnostic use to determine the concentration of alpha-fetoprotein (AFP) in the following: • human serum and in amniotic fluid from the sample obtained at the time of 15 to 20 weeks of pregnancy, as a supportive test for the detection of open neural tube defects (NTD) when used in combination with ultrasound and amniotic fluid X-ray fluoroscopy, • human serum, to support the management of non-seminomatous testicular cancer by use in combination with clinical examination, histopathology and other clinical evaluation techniques, using the ADVIA Centaur CP, ADVIA Centaur XP and ADVIA Centaur XPT systems. - ADVIA Centaur CAL D: It is intended for in vitro diagnostic use to calibrate the following tests on the ADVIA Centaur system: AFP, CEA.
- Registration Date
- Aug 30, 2024
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Access comprehensive regulatory information for IVD Department quantitative AFP testing 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 2402490ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH SIEMENS HEALTHCARE.
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