Vietnam MOH registration 2402889ĐKLH/BYT-HTTB

IVD Department quantitative testing of Low Molecular Weight Heparin (LMWH) and Unfractionated Heparin (UFH)

VN: Bộ IVD xét nghiệm định lượng Heparin trọng lượng phân tử thấp (LMWH) và Heparin không phân đoạn (UFH)

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

Registration details

Analysis ID: 2402889ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-230307-0019
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: HYPHEN BioMed
Manufacturer Country: Theo theo phụ lục
Product Owner: HYPHEN BioMed
Authorized Representative: CÔNG TY TNHH SYSMEX VIỆT NAM

Technical details

Intended Use: 1-2. The chromogenic anti-Xa assay method is used to quantitatively determine the concentration of FXa inhibitors in citrate-anticoagulated human blood plasma in vitro. This method is used to monitor patients treated with Heparin (UFH/LMWH), Arixtra®, Orgaran® and to support diagnosis by detecting the presence of resistance (Apixaban, Edoxaban, Rivaroxaban) in patients treated with anticoagulants. The in-vitro diagnostic device is intended for professional use in the laboratory. ; 3. It is used to calibrate the LMWH (Low Molecular Weight Heparin) and UFH (Unfractionated Heparin) assays when a cross-reactivity (LMWH/UFH) has been confirmed on the same calibration curve by the automated quantitative method. The in-vitro diagnostic device is intended for professional use in the laboratory. ; 4. It is used to calibrate the concentration of UFH (Unfractionated Heparin) by the automated quantitative method. The in-vitro diagnostic device is intended for professional use in the laboratory. ; 5-7. It is used to control the quality of the concentration of UFH (Unfractionated Heparin) by the automated quantitative method. The in-vitro diagnostic device is intended for professional use in the laboratory. ; 8-13. It is used to control the quality of the concentration of LMWH (Low Molecular Weight Heparin) by the automated quantitative method. The in-vitro diagnostic device is intended for professional use in the laboratory.

Dates and status

Registration Date: Oct 22, 2024

About this record

Access comprehensive regulatory information for IVD Department quantitative testing of Low Molecular Weight Heparin (LMWH) and Unfractionated Heparin (UFH) 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 2402889ĐKLH/BYT-HTTB and manufactured by HYPHEN BioMed. The authorized representative in Vietnam is CÔNG TY TNHH SYSMEX VIỆT NAM.

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