IVD Department Quantitative NT-ProBNP Testing
Vietnam·Risk Class TTBYT Loại C·Theo theo phụ lục·Siemens Healthineers·Registered Jun 24, 2024- Analysis ID
- 2400893ĐKLH/BYT-HTTB
- Submission ID
- 17003875/ĐKLH-BYT-TB-CT
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Siemens Healthineers
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Siemens Healthineers
- Authorized Representative
- CÔNG TY TNHH SIEMENS HEALTHCARE
- Intended Use
- - IMMULITE 2000 NT-proBNP: Used in vitro diagnostic with the IMMULITE 2000 Systems - to quantitate the concentration of N-terminal pro-brain natriuretic peptide (NT-proBNP) in heparin-anticoagulated blood plasma as a supportive diagnostic test for individuals suspected of having congestive heart failure. The test is indicated as an additional test to stratify the risk of patients with acute coronary syndrome and congestive heart failure. - IMMULITE Control Module NT-proBNP: The IMMULITE NT-proBNP Control Module is a three-level control, intended for use with the IMMULITE/IMMULITE 1000 Turbo and IMMULITE 2000 NT-proBNP tests. It is used as a support in the daily monitoring of the performance of the test.
- Registration Date
- Jun 24, 2024
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Access comprehensive regulatory information for IVD Department Quantitative NT-ProBNP Testing 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 2400893ĐKLH/BYT-HTTB and manufactured by Siemens Healthineers. The authorized representative in Vietnam is CÔNG TY TNHH SIEMENS HEALTHCARE.
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