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Medical Devices Public Assessment Reports
Medical Devices Public Assessment Reports
Access the Public Assessment Reports for medical devices and in-vitro diagnostic devices assessed by the Tanzania Medicines and Medical Devices Authority (TMDA).
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Public Assessment Report for CUPIKIT (MALARIA PF-PV Rapid Diagnostic Kit), Version number 2.0, 18.05.2026
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Public Assessment Report For XPERT® HCV Viral Load (XPERT® HCV Viral Load), Version number 2.0, 18.05.2026
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Public Assessment Report For Parascreen (Malaria P.f / PAN Rapid Test), Version number 2.0, 18.05.2026
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Public Assessment Report For KAS HEPATITIS B (HBsAg) Rapid Test (Hepatitis B Surface Antigen (HBsAg) Test Kit), Version number 2.0, 18.05.2026
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Public Assessment Report For XPERT HIV-1 QUAL XC (HIV-1 Assay Cartridge), Version number 2.0, 18.05.2026
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Public Assessment Report for Smart (HIV 1/2 RAPID Test Cassette), Version number 2.0, 18.05.2026
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Public Public Assessment Report for on Call® Plus Code Free Blood Glucose Monitoring System, Version number 2.0, 18.05.2026
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Public Assessment Report for Maxline HIV 1 & 2 Tri-Line Rapid Antibody Test Kit for Hiv 1/2, Version number 2.0, 18.05.2026
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Public Assessment Report For Wondfo (Malaria P.F (HRP2/PLDH) Test), Version number 2.0, 18.05.2026
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Public Assessment Report For Xpert® MTB / RIF Ultra (GeneXpert), Version number 2.0, 18.05.2026
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Public Assessment Report for Sinocare – iCan i3 Continuous Glucose Monitoring System, Version number 2.0, 18.05.2026
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Public Assessment Report for Prudiagnos Malaria PF/PAN Antigen Test Kit, Version number 2.0, 18.05.2026
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Public Assessment Report For XPERT® MTB/RIF Ultra MDR-TB/XDR-TB Nucleic Acid IVD, KIT, Nucleic Acid Technique (NAT), Version number 2.0, 18.05.2026
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Public Assessment Report for XPERT HIV-1 VL XC (Rapid Viral Load Testing Kit), Version number 2.0, 18.05.2026
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Public Assessment Report for (Cupikit Malaria PF/PAN Rapid Diagnostic Kit), Version number 2.0, 18.05.2026
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Public Assessment Report for First Response (Syphilis Anti-TP Card Test), Version number 2.0, 18.05.2026
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Public Assessment Report for KAS MALARIA PF ANTIGEN Rapid Test, Version number 2.0, 29/03/2024
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Public Assessment Report for CARESTARTTM MALARIA PF/PAN(HRP2/PLDH) AG COMBO RDT, Version number 2.0, 09/09/2024
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Public Assessment Report for SMART MALARIA P.F/ PAN AG Rapid Test, Version number v2.0, 09-09-2024
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Public Assessment Report for of LABOREX HEPATITIS C TEST STRIPS (Whole Blood/Serum/Plasma), Version number 2.0, 12/09/2024
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Public Assessment Report for FASTEP TB-W23 Tuberculosis Rapid Test Device, Version number 2.0, 11/09/2024
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Public Assessment Report for cobas® pulse GLUCOSE Monitoring System IVD, Point Of Care, Version number 2.0, 09/09/2024
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Public Assessment Report for Accuquik SYPHILIS AB Rapid Diagnostics Test Kit, Version number 2.0, 29/03/2024
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Public Assessment Report for WONDFO HIV SELF-TEST, Version number 2.0, 29/03/2024
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Public Assessment Report for (CheckNow™, HIV Self-Test), Version number 2.0, 29/03/2024
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Public Assessment Report for Smart HCV AB Rapid Test Kit, Version number 2.0, 29/04/2023
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Public Assessment Report for Malaria P.F/Pan Rapid Test Cassette, Version number 2.0, 29/03/2024
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Public Assessment Report for KAS MALARIA PF/PAN Antigen Rapid Test, Version number 0.1, 29/03/2024
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Public Assessment Report for KAS Hepatitis C (HCV) Rapid Test, Version number 0.1, 29/03/2024
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Public Assessment Report For XPERT HIV-1 QUAL XC (HIV-1 Assay Cartridge), Version number 2.0, 18.05.2026
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Public Assessment Report for Smart (HIV 1/2 RAPID Test Cassette), Version number 2.0, 18.05.2026
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Public Public Assessment Report for on Call® Plus Code Free Blood Glucose Monitoring System, Version number 2.0, 18.05.2026
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Public Assessment Report for Maxline HIV 1 & 2 Tri-Line Rapid Antibody Test Kit for Hiv 1/2, Version number 2.0, 18.05.2026
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Public Assessment Report For Wondfo (Malaria P.F (HRP2/PLDH) Test), Version number 2.0, 18.05.2026
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Public Assessment Report For Xpert® MTB / RIF Ultra (GeneXpert), Version number 2.0,18.05.2026
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Public Assessment Report for LH Ovulation Rapid Test , Version number 2.0, 18.08.2025
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Public Assessment Report for Umoja’s HCG Strip One Step HCG Urine Pregnancy Test, Version number 2.0, 25.05.2026
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Public Assessment Report for Duke HCG Pregnancy Test Strip, Version number 2.0, 25.05.2025
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Public Assessment Report for Medi Test HCG Urine Pregnancy Test, Version number 2.0, 25.05.2026
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Public Assessment Report for Anytime Male Lubricated Latex Condoms, Version number 2.0, 25.05.2026
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Public Assessment Report for Cordx LH Ovulation Test Midstream, Version number 2.0, 26.05.2026
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Public Assessment Report for CORDX HCG Pregnancy Test Midstream Urine, Version number 2.0, 26.05.2026
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