Vietnam MOH registration 2403725ĐKLH/BYT-HTTB

CA 15-3 Quantitative Testing Drug

VN: Thuốc thử xét nghiệm định lượng CA 15-3

Vietnam·Risk Class TTBYT Loại C·Elecsys CA 15-3 II·Roche Diagnostics (Suzhou) Ltd.·Registered Nov 19, 2024

Registration details

Analysis ID: 2403725ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-230621-0003
Product Type: Elecsys CA 15-3 II
Product Code: 07027001214

Company information

Manufacturer: Roche Diagnostics (Suzhou) Ltd.
Manufacturer Country: CHINA
Authorized Representative: CÔNG TY TNHH ROCHE VIỆT NAM

Technical details

Intended Use: 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

Registration Date: Nov 19, 2024

About this record

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.

This page provides complete technical specifications, regulatory compliance details. 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.