IVD Department Quantitative PAPP-A Testing
Vietnam·Risk Class TBYT Loại C·Theo theo phụ lục·Registered Nov 14, 2024- Analysis ID
- 2403592ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-240826-0001
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Authorized Representative
- CÔNG TY TNHH ROCHE VIỆT NAM
- Intended Use
- Elecsys PAPP-A: An in vitro immunoassay for the quantitative determination of pregnancy-related plasma protein A in human serum. This test is used as a screening test to provide information in combination with other information to assess the risk of trisomy 21 (Down syndrome) in the first trimester of pregnancy. Further testing is required to diagnose abnormal chromosomal conditions. The fluorescent immunoassay "ECLIA" (electrochemiluminescence immunoassay "ECLIA") is used for the cobas e immunoassay analyzer. PAPP-A CalSet: The PAPP-A CalSet is used to calibrate the quantitative Elecsys PAPP-A immunoassay on the cobas e immunoassay analyzer.
- Registration Date
- Nov 14, 2024
Companies providing products similar to "IVD Department Quantitative PAPP-A Testing"
Recently registered similar products
Access comprehensive regulatory information for IVD Department Quantitative PAPP-A Testing in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại C medical device is registered under number 2403592ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.
This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including Theo phụ lục, and 1 recent registrations in the same category. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.