IVD Parasite Infection - Immune - Vietnam Registration 240001394/PCBB-HCM
Access comprehensive regulatory information for IVD Parasite Infection - Immune 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 240001394/PCBB-HCM and manufactured by Acro Biotech, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH THƯƠNG MẠI Y TẾ PHÚ GIA.
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Device Details
Registration Details
240001394/PCBB-HCM
000.00.19.H29-240626-0007
Theo theo phụ lục
Theo phụ lục
Technical Details
1. Leishmania IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is an immunochromatographic rapid test for the qualitative detection of Leishmania-specific IgG and IgM antibodies in whole blood, serum, or plasma. 2. Filariasis IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is an immunochromatographic rapid test for the qualitative detection of IgG and IgM antibodies against the filarial parasites W. Bancrofti and B. Malayi in whole blood, serum, or plasma, to aid in the diagnosis of filariasis. 3. Filariasis IgG/IgM Rapid Test Cassette (Serum/Plasma) is an immunochromatographic rapid test for the qualitative detection of IgG and IgM antibodies against the filarial parasites W. Bancrofti and B. Malayi in serum or plasma, to aid in the diagnosis of filariasis.
Dates and Status
Jul 08, 2024