Vietnam MOH registration 2403150ĐKLH/BYT-HTTB

CA 125 Quantitative Testing Reagent

VN: Thuốc thử xét nghiệm định lượng CA 125

Vietnam·Risk Class TTBYT Loại C·Elecsys CA 125 II·Roche Diagnostics GmbH·Registered Nov 02, 2024

Registration details

Analysis ID: 2403150ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-240725-0002
Product Type: Elecsys CA 125 II
Product Code: 09755586190

Company information

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

Technical details

Intended Use: In vitro quantification of OC 125 antigen-reactive determinants in human serum and plasma. These antigen-determinants bind to high-molecular-weight glycoproteins in the serum and plasma of women with advanced epithelial ovarian cancer (except those with low-risk malignancy). This test is used to support the detection of residual or recurrent epithelial ovarian cancer in patients who have undergone initial treatment and are considered candidates for further treatment. Additionally, this test is prescribed to measure CA 125 according to protocol to support the management of cancer patients. This test is also used in combination with the Elecsys HE4 test within the context of ROMA (Risk Algorithm for Ovarian Cancer) to assess the risk of epithelial ovarian cancer in pre- and post-menopausal women with pelvic mass symptoms. The "ECLIA" (electrochemiluminescence immunoassay "ECLIA") is used for the cobas e immunoassay system.

Dates and status

Registration Date: Nov 02, 2024

About this record

Access comprehensive regulatory information for CA 125 Quantitative Testing Reagent 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 2403150ĐKLH/BYT-HTTB and manufactured by Roche Diagnostics GmbH. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.

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