IVD Parasitic Infection - Immunity: E. histolytica IgG, Fasciola IgG, Schistosoma IgG, Toxocara IgG, Echinococcus IgG
Vietnam·Risk Class TBYT Loại B·Theo theo phụ lục·ImmunoCentrix·Registered Nov 08, 2024- Analysis ID
- 240002561/PCBB-HCM
- Submission ID
- 000.00.19.H29-241101-0031
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- ImmunoCentrix
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- ImmunoCentrix
- Authorized Representative
- CÔNG TY TNHH THƯƠNG MẠI DỊCH VỤ HASPHARM
- Intended Use
- 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.
- Registration Date
- Nov 08, 2024
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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