Vietnam MOH registration 2403389ĐKLH/BYT-HTTB

IVD Department quantitative d-dimer test

VN: Bộ IVD xét nghiệm định lượng d‑dimer

Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Registered Nov 06, 2024

Registration details

Analysis ID: 2403389ĐKLH/BYT-HTTB
Submission ID: 17004105/ĐKLH-BYT-TB-CT
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Authorized Representative: CÔNG TY TNHH ROCHE VIỆT NAM

Technical details

Intended Use: Roche CARDIAC D-Dimer: RocheCARDIACD‑Dimer is an in vitro diagnostic quantitative immunodetection test designed to determine d-dimer in heparinized venous blood, to be used with the cobash232 instrument. The RocheCARDIACD‑Dimer test is used to support the diagnosis of patients suspected of having deep vein thrombosis and pulmonary embolism. A negative d-dimer test result can exclude these conditions with high probability. The RocheCARDIACD‑Dimer test is performed near the patient. It is not intended for self-testing. Roche CARDIAC Control D-Dimer: RocheCARDIACControlD‑Dimer is used in conjunction with the RocheCARDIAC D‑Dimer test to perform quality control on the cobash232 instrument. RocheCARDIACControlD‑Dimer is performed near the patient. It is not intended for self-testing.

Dates and status

Registration Date: Nov 06, 2024

About this record

Access comprehensive regulatory information for IVD Department quantitative d-dimer test 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 2403389ĐKLH/BYT-HTTB. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.

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