HE4 Quantitative Testing Drug - Vietnam Registration 2400503ĐKLH/BYT-HTTB
Access comprehensive regulatory information for HE4 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 2400503ĐKLH/BYT-HTTB and manufactured by Roche Diagnostics (Suzhou) Ltd.. 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 Roche Diagnostics GmbH, Roche Diagnostics (Suzhou) Ltd., 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.
Device Details
Registration Details
2400503ĐKLH/BYT-HTTB
000.00.04.G18-210326-0030
Elecsys HE4
05950929214
Technical Details
The immunoassay test is used to quantify HE4 in human serum and plasma. The test is used to support the monitoring of recurrent or progressive disease in patients with ovarian cancer. The time course of the HE4 values for the patient must be used in combination with other clinical results used in the monitoring of ovarian cancer. This test is also used in combination with the Elecsys CA 125 II test to support the evaluation of the risk of ovarian cancer in pre- and post-menopausal women with pelvic mass symptoms. The results must be interpreted in combination with other methods according to the standard clinical management guidelines. The "ECLIA" fluorescent chemiluminescence immunoassay is used on the Elecsys and cobas e immunoassay analyzers.
Dates and Status
Apr 10, 2024