Vietnam MOH registration 2402949ĐKLH/BYT-HTTB

Quantitative Testing Control Material 25 Cancer Fingerprints

VN: Vật liệu kiểm soát xét nghiệm định lượng 25 dấu ấn ung thư

Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Registered Oct 22, 2024

Registration details

Analysis ID: 2402949ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-240221-0007
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Authorized Representative: VĂN PHÒNG ĐẠI DIỆN LIFE TECHNOLOGIES HOLDINGS PTE. LTD. TẠI THÀNH PHỐ HỒ CHÍ MINH

Technical details

Intended Use: MAS® T-Marker is used in clinical laboratories as a quantitative control material to monitor the analytical processes for the purpose of detecting cancer markers in human serum. It is recommended to use T-Marker together with the patient's serum samples when performing the test for any component listed in the accompanying value table. The test values provided for the specific analytical systems are listed in the accompanying value table. The operator can compare the observed values with the expected range to ensure the consistent performance of the test reagents and equipment.

Dates and status

Registration Date: Oct 22, 2024

About this record

Access comprehensive regulatory information for Quantitative Testing Control Material 25 Cancer Fingerprints 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 2402949ĐKLH/BYT-HTTB. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN LIFE TECHNOLOGIES HOLDINGS PTE. LTD. TẠI THÀNH PHỐ HỒ CHÍ MINH.

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