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IVD Parasitic Infection - Immunity: E. histolytica IgG, Fasciola IgG, Schistosoma IgG, Toxocara IgG, Echinococcus IgG - Vietnam Registration 240002561/PCBB-HCM

Access comprehensive regulatory information for IVD Parasitic Infection - Immunity: E. histolytica IgG, Fasciola IgG, Schistosoma IgG, Toxocara IgG, Echinococcus IgG in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại B medical device is registered under number 240002561/PCBB-HCM and manufactured by ImmunoCentrix. The authorized representative in Vietnam is CÔNG TY TNHH THƯƠNG MẠI DỊCH VỤ HASPHARM.

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240002561/PCBB-HCM
Registration Details
Vietnam MOH Registration: 240002561/PCBB-HCM
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Device Details

IVD Parasitic Infection - Immunity: E. histolytica IgG, Fasciola IgG, Schistosoma IgG, Toxocara IgG, Echinococcus IgG
VN: Cụm IVD Nhiễm ký sinh trùng - Miễn dịch: E. histolytica IgG, Fasciola IgG, Schistosoma IgG, Toxocara IgG, Echinococcus IgG
Risk Class TBYT Loại B

Registration Details

240002561/PCBB-HCM

000.00.19.H29-241101-0031

Theo theo phụ lục

Theo phụ lục

Company Information

Theo theo phụ lục

ImmunoCentrix

Technical Details

1. E. histolytica IgG: ImmunoCentrix E. histolytica ELISA is an enzyme-linked immunosorbent assay (ELISA) test for the qualitative detection of antibodies against E. histolytica in human serum or plasma samples. This test is performed only by trained medical laboratory technicians. 2. Fasciola (hepatica) IgG: ImmunoCentrix Fasciola IgG is used to screen serum for qualitative detection of IgG antibodies against Fasciola hepatica by the enzyme-linked immunosorbent assay (ELISA) technique. 3. Schistosoma IgG: ImmunoCentrix Schistosoma IgG is used to determine qualitative serum antibodies in humans, primarily IgG, against Schistosoma spp. by the ELISA technique. 4. Toxocara IgG: ImmunoCentrix Toxocara IgG ELISA is an enzyme-linked immunosorbent assay (ELISA) test for the qualitative detection of antibodies against Toxocara in human serum or plasma samples. This test is performed only by trained medical laboratory technicians. 5. Echinococcus IgG: ImmunoCentrix Echinococcus IgG is used to screen serum for qualitative detection of IgG antibodies against Echinococcus sp. by the enzyme-linked immunosorbent assay (ELISA) technique.

Dates and Status

Nov 08, 2024