IVD Department quantitative d-dimer test - Vietnam Registration 2403389ĐKLH/BYT-HTTB
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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Device Details
Registration Details
2403389ĐKLH/BYT-HTTB
17004105/ĐKLH-BYT-TB-CT
Theo theo phụ lục
Theo phụ lục
Technical Details
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
Nov 06, 2024