Vietnam MOH registration 2403374ĐKLH/BYT-HTTB

Comprehensive Quantitative PSA Test Kit

VN: Thuốc thử xét nghiệm định lượng PSA toàn phần

Vietnam·Risk Class TTBYT Loại C·Elecsys total PSA·Roche Diagnostics GmbH·Registered Nov 06, 2024

Registration details

Analysis ID: 2403374ĐKLH/BYT-HTTB
Submission ID: 18006370/ĐKLH-BYT-TB-CT
Product Type: Elecsys total PSA
Product Code: 08791716190

Company information

Manufacturer: Roche Diagnostics GmbH
Manufacturer Country: GERMANY
Authorized Representative: CÔNG TY TNHH ROCHE VIỆT NAM

Technical details

Intended Use: This test is used in vitro diagnostic to quantify the total specific prostate antigen (free+complexed) in human serum and plasma, and is recommended to measure the total PSA along with digital rectal examination (DRE) to aid in the detection of prostate cancer in men aged 50 and above. Prostate biopsy is required for the diagnosis of prostate cancer. Additionally, the test is recommended to measure tPSA over time to support the monitoring of cancer patients. The "ECLIA" fluorescent immunoassay is used in the cobase601 and cobase602 diagnostic test systems.

Dates and status

Registration Date: Nov 06, 2024

About this record

Access comprehensive regulatory information for Comprehensive Quantitative PSA Test Kit 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 2403374ĐKLH/BYT-HTTB and manufactured by Roche Diagnostics GmbH. 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.