MP Diagnostics ASSURE H. pylori Rapid Test (Qualitative Antibody Test for H. pylori in serum, plasma, and whole blood from humans) - Vietnam Registration 240000525/PCBB-HCM
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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Device Details
Registration Details
240000525/PCBB-HCM
000.00.19.H29-240304-0017
Theo theo phụ lục
Theo phụ lục
Technical Details
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
Dates and Status
Mar 07, 2024