MP Diagnostics ASSURE H. pylori Rapid Test (Qualitative Antibody Test for H. pylori in serum, plasma, and whole blood from humans)
Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·MP BIOMEDICALS ASIA PACIFIC PTE. LTD·Registered Mar 07, 2024- Analysis ID
- 240000525/PCBB-HCM
- Submission ID
- 000.00.19.H29-240304-0017
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- MP BIOMEDICALS ASIA PACIFIC PTE. LTD
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- MP BIOMEDICALS ASIA PACIFIC PTE. LTD
- Authorized Representative
- CÔNG TY TNHH THIẾT BỊ Y TẾ HOÀNG LÊ
- Intended Use
- MP Diagnostics ASSURE H.pylori Rapid Test is an immunological test device that quickly detects the presence of Helicobacter pylori-specific IgG antibodies in serum, plasma, or whole blood. It is intended as a clinical diagnostic test to diagnose H. pylori infection in patients with gastrointestinal disorders. The presence of antibodies against the recombinant infection marker (CIM) is an indicator of active infection
- Registration Date
- Mar 07, 2024
Access comprehensive regulatory information for MP Diagnostics ASSURE H. pylori Rapid Test (Qualitative Antibody Test for H. pylori in serum, plasma, and whole blood from humans) 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 240000525/PCBB-HCM and manufactured by MP BIOMEDICALS ASIA PACIFIC PTE. LTD. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ Y TẾ HOÀNG LÊ.
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