Quantitative AFP Testing Reference Standard Drug Assay Kit
Vietnam·Risk Class TTBYT Loại C·IMMULITE/ IMMULITE 1000 AFP (Name on Label: IMMULITE/ IMMULITE 1000 Systems AFP)·Siemens Healthcare Diagnostics Products Limited·Registered Jun 24, 2024- Analysis ID
- 2400881ĐKLH/BYT-HTTB
- Submission ID
- 17001973/ĐKLH-BYT-TB-CT
- Product Type
- IMMULITE/ IMMULITE 1000 AFP (Name on Label: IMMULITE/ IMMULITE 1000 Systems AFP)
- Product Code
- 10381162/ LKAP1
- Manufacturer
- Siemens Healthcare Diagnostics Products Limited
- Manufacturer Country
- UNITED KINGDOM
- Product Owner
- Siemens Healthineers
- Authorized Representative
- CÔNG TY TNHH SIEMENS HEALTHCARE
- Intended Use
- 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.
- Registration Date
- Jun 24, 2024
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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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