IVD Blood Clotting (Coagulation)
Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Boditech Med Inc.·Registered Apr 05, 2024- Analysis ID
- 240000727/PCBB-HN
- Submission ID
- 000.00.19.H26-240131-0004
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Boditech Med Inc.
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Boditech Med Inc.
- Authorized Representative
- CÔNG TY TNHH VẠN NIÊN
- Intended Use
- AFIAS D-Dimer Neo is a fluorescent immunoassay (FIA) test for quantifying D-Dimer in whole blood/plasma. It is very useful in supporting the management and monitoring of treatment of patients with thromboembolic disorders. It is intended for in vitro diagnostic use only. Boditech D-Dimer Control is designed to be used in in vitro diagnostic testing to control the quality of the test kit. It is intended for in vitro diagnostic use only. ichroma™ D-Dimer Neo is a fluorescent immunoassay (FIA) test for quantifying D-Dimer in whole blood/plasma. It is very useful in supporting the management and monitoring of treatment of patients with thromboembolic disorders. It is intended for in vitro diagnostic use only.
- Registration Date
- Apr 05, 2024
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Access comprehensive regulatory information for IVD Blood Clotting (Coagulation) 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 240000727/PCBB-HN and manufactured by Boditech Med Inc.. The authorized representative in Vietnam is CÔNG TY TNHH VẠN NIÊN.
This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including Theo theo phụ lục, and 1 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.