Vietnam MOH registration 2403552ĐKLH/BYT-HTTB

IVD Department quantitative testing of the fibrin degradation product (D-Dimer and X-oligomer)

VN: Bộ IVD xét nghiệm định lượng sản phẩm giáng hóa fibrin (D‑Dimer và X‑oligomer)

Vietnam·Risk Class TBYT Loại C·Theo theo phụ lục·Registered Nov 14, 2024

Registration details

Analysis ID: 2403552ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-240825-0001
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: D-DI2: In vitro diagnostic test used to quantitatively measure the degradation products of fibrin (D-Dimer and X-oligomer) in human blood plasma on cobas systems. Combined with the clinical evaluation of low probability, a normal result (<0.5 µg FEUa)/mL) excludes deep vein thrombosis (DVT) and pulmonary embolism (PE) with high sensitivity. a) Equivalent to Fibrinogen. D-Dimer Gen.2 Calibrator Set: D-DimerGen.2Calibrator Set is used to calibrate the quantitative methods of Roche on Roche clinical chemistry analyzers as per the specifications in the attached value document.; D-Dimer Gen.2 Control I/II: D-Dimer Gen.2 ControlI/II is used in quality control to assess the accuracy and precision of the quantitative methods specified in the attached value document.

Dates and status

Registration Date: Nov 14, 2024

About this record

Access comprehensive regulatory information for IVD Department quantitative testing of the fibrin degradation product (D-Dimer and X-oligomer) in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại C medical device is registered under number 2403552ĐKLH/BYT-HTTB. 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.