IVD Quantitative D-Dimer Test Kit
Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Registered Mar 28, 2024- Analysis ID
- 240000661/PCBB-HN
- Submission ID
- 000.00.19.H26-240309-0002
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Authorized Representative
- CÔNG TY TNHH VẠN NIÊN
- Intended Use
- D-Dimer FS: A diagnostic test to determine the concentration of D-dimer in blood serum on BioMajesty JCABM6010/C. TruCal D-Dimer: A calibration standard for the DiaSys test to determine the concentration of D-Dimer in vitro on the fluorescence system. TruLab D-Dimer Level 1: A quality control material for the test to monitor the performance of the D-Dimer concentration determination in vitro. TruLab D-Dimer Level 2: A quality control material for the test to monitor the performance of the D-Dimer concentration determination in vitro.
- Registration Date
- Mar 28, 2024
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Access comprehensive regulatory information for IVD Quantitative D-Dimer Test Kit in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 240000661/PCBB-HN. The authorized representative in Vietnam is CÔNG TY TNHH VẠN NIÊN.
This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH, Theo theo phụ lục, and 2 recent registrations in the same category. 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.