Registered Transfusion Transmitted Infection (TTI) Test Kits
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List of Transfusion Transmitted Infection (TTI) Test Kits Registerd with Drug Regulatory Authority as of 20 November 2018
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S.No.Brand NameGeneric NameApproval NoApproval DateManufacturerPack SizePack TypeValidityMAH in Bhutan
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1SD Bioline HCV (02FK10)HCV Rapid Test KitBHU-DRA-MD-0131-Jul-18Standard Diagnostics Inc, 65, Borahagal-ro, Giheung-gu, Yongin-si, Gyeonggi-do, South Korea30 test per kitFoil pouch packed in carton box30-Jul-21Wamling Pharmceuticals & Medical Supplies, Thimphu, Bhutan
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2SD Bioline Malaria Ag P.F/Pan (05FK60)Malaria Ag P.F/Pan Rapid Test KitBHU-DRA-MD-0231-Jul-18Standard Diagnostics Inc, 65, Borahagal-ro, Giheung-gu, Yongin-si, Gyeonggi-do, South Korea25 test per kitFoil pouch packed in carton box30-Jul-21Wamling Pharmceuticals & Medical Supplies, Thimphu, Bhutan
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3SD Bioline Malaria Ag P.F/PV(05FK30)Malaria Ag P.F/PV Rapid Test KitBHU-DRA-MD-0331-Jul-18Standard Diagnostics Inc, 65, Borahagal-ro, Giheung-gu, Yongin-si, Gyeonggi-do, South Korea30 test per kitFoil pouch packed in carton box30-Jul-21Wamling Pharmceuticals & Medical Supplies, Thimphu, Bhutan
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4SD Bioline HbsAg (01FK10)HbsAg Rapid Test KitBHU-DRA-MD-0431-Jul-18Standard Diagnostics Inc, 65, Borahagal-ro, Giheung-gu, Yongin-si, Gyeonggi-do, South Korea30 test per kitFoil pouch packed in carton box30-Jul-21Wamling Pharmceuticals & Medical Supplies, Thimphu, Bhutan
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5SD Bioline Syphilis 3.0 (06FK11)Syphilis 3.0 Rapid Test KitBHU-DRA-MD-0531-Jul-18Standard Diagnostics Inc, 65, Borahagal-ro, Giheung-gu, Yongin-si, Gyeonggi-do, South Korea30 test per kitFoil pouch packed in carton box30-Jul-21Wamling Pharmceuticals & Medical Supplies, Thimphu, Bhutan
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6SD Bioline HIV-1/2 3.0 (03FK10)HIV-1/2 3.0 Rapid Test KitBHU-DRA-MD-0631-Jul-18Standard Diagnostics Inc, 65, Borahagal-ro, Giheung-gu, Yongin-si, Gyeonggi-do, South Korea30 test per kitFoil pouch packed in carton box30-Jul-21Wamling Pharmceuticals & Medical Supplies, Thimphu, Bhutan
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7N.ASyphilis RPR Test KitBHU-DRA-MD-0719-Nov-18Human Gesellschaft fur Biochemica und Diagnostica mbH (Human), Max-Planck-Ring 21, 65205 Wiesbaden, Germany.100 tests100 test packed in carton box18-Nov-21Dzambala Pharmceuticals & Medical Supplies, Thimphu, Bhutan
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