CA 15-3 Quantitative Testing Drug - Vietnam Registration 2403725ĐKLH/BYT-HTTB
Access comprehensive regulatory information for CA 15-3 Quantitative Testing Drug 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 2403725ĐKLH/BYT-HTTB and manufactured by Roche Diagnostics (Suzhou) Ltd.. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.
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Device Details
Registration Details
2403725ĐKLH/BYT-HTTB
000.00.04.G18-230621-0003
Elecsys CA 15-3 II
07027001214
Technical Details
In vitro immunoassay for quantifying CA 15-3 in human serum and plasma helps support the monitoring of breast cancer patients. Combined with other clinical and diagnostic procedures, the serial testing with this assay helps support ▪ the early detection of recurrence in stage II and III breast cancer patients who have received prior treatment ▪ the monitoring of treatment response in metastatic breast cancer patients. The electrochemiluminescence immunoassay (ECLIA) is used in the cobas e immunoassay system.
Dates and Status
Nov 19, 2024