IVD Department quantitative CA 15-3
Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Registered Nov 06, 2024- Analysis ID
- 2403449ĐKLH/BYT-HTTB
- Submission ID
- 000.00.04.G18-211025-0018
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Authorized Representative
- CÔNG TY TNHH ROCHE VIỆT NAM
- Intended Use
- Elecsys CA 15-3 II: An in vitro immunoassay test used to quantify CA15-3 in human serum and plasma, aiding in the monitoring of breast cancer patients. Combined with other clinical and diagnostic procedures, the sequential testing procedure with this test helps to support: ▪ Early detection of recurrence in stage II and III breast cancer patients who have received prior treatment ▪ Monitoring of treatment response in metastatic breast cancer patients The ECLIA fluorescent chemiluminescence immunoassay is used on Elecsys and cobase immunoassay analyzers. CA 15-3 II CalSet: The CA 15-3 II CalSet is used to calibrate the quantitative Elecsys CA 15-3 II immunoassay test on the cobas e immunoassay analyzer.
- Registration Date
- Nov 06, 2024
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Access comprehensive regulatory information for IVD Department quantitative CA 15-3 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 2403449ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.
This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including Beckman Coulter, Inc., Theo phụ lục, and 2 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.