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S.No.Brand NameGeneric NameApproval No.Approval DateManufacturerPack SizePack TypeValidityMAH in Bhutan
16Alere HIV ComboHIV Combo Test KitBHU-DRA-MD-1627-May-19Alere Medical Co., Ltd., Chiba plant,357 Matsuhida, Chiba 270-2214 Japan10 test/kitAluminium coated plastic pouch26-May-2022Wamling Pharmceuticals & Medical Supplies, Thimphu, Bhutan
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
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
3SD Bioline Malaria Ag P.F/PV(05FK30)Malaria Ag P.f/P.v 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
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
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
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
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 tests/kit100 test packed in carton box18-Nov-21Dzambala Pharmceuticals & Medical Supplies, Thimphu, Bhutan
8Alere Determine HBsAg Hepatitis B Surface antigen test kit (7D2543)Hepatitis B Surface antigen test kitBHU-DRA-MD-0816-Apr-19Alere Medical Co., Ltd., Chiba plant,357 Matsuhida, Chiba 270-2214 Japan10 test cards/kitAluminium coated plastic bag15-Apr-22Wamling Pharmceuticals & Medical Supplies, Thimphu, Bhutan
9Alere Determine HIV-1/HIV-2 (7D2343)HIV-1/HIV-2 rapid test kitBHU-DRA-MD-0916-Apr-19Alere Medical Co., Ltd., Chiba plant,357 Matsuhida, Chiba 270-2214 Japan10 10-test cards/kitAluminium coated plastic bag15-Apr-22Wamling Pharmceuticals & Medical Supplies, Thimphu, Bhutan
10Alere Determine Syphilis TP (7D2443)Syphilis Test kitBHU-DRA-MD-1016-Apr-19Alere Medical Co., Ltd., Chiba plant,357 Matsuhida, Chiba 270-2214 Japan10 test cards/kitAluminium coated plastic bag15-Apr-22Wamling Pharmceuticals & Medical Supplies, Thimphu, Bhutan
11Diagnostic kit for HIV (1+2) Antibody (Colloidal Gold) V2HIV 1+2 rapid test kitBHU-DRA-MD-1116-Apr-19Shanghai Kehua Bio-engineering Co., Ltd, 1189 North Qinzhou Road, Shanghai, P.R.China50 test casettes/kitAluminium coated plastic pouch15-Apr-22Norling Pharmceuticals & Medical Supplies, Thimphu, Bhutan
12SD Bioline Malaria Ag P.f/P.v (05FK80)Malaria Test KitBHU-DRA-MD-1224-Apr-19Standard Diagnostic Inc, 65 Borahagal-ro, Giheung-gu, Yongin-si, gyeonggi-do, Republic of Korea.25 test/kitAluminium coated plastic pouch23-Apr-22Wamling Pharmceuticals & Medical Supplies, Thimphu, Bhutan
13CareStartâ„¢ Malaria HRP2/pLDH (Pf/Pv) COMBO RDTMalaria Pf/Pv (HRP2/pLDH) Ag Combo RDTBHU-DRA-MD-1325-Apr-19Access Bio Inc. 65 Clyde Road, Suite A, Somerset NJ08873, U.S.A25 test/kitPlastic packet24-Apr-22Norling Pharmceuticals & Medical Supplies, Thimphu, Bhutan
14CareStartâ„¢ Malaria pLDH (PAN) Ag RDTMalaria PAN (pLDH) Ag RDTBHU-DRA-MD-1425-Apr-19Access Bio Inc. 65 Clyde Road, Suite A, Somerset NJ08873, U.S.A25 test/kitPlastic packet24-Apr-22Norling Pharmceuticals & Medical Supplies, Thimphu, Bhutan
15OnSite® Syphilis Ab Rapid TestSyphilis Rapid Test KitBHU-DRA-MD-1525-Apr-19CKT Biotech, Inc. 13855 Stowe Drive, Poway, CA 92064 USA.100 test/kitPlastic packet24-Apr-22Norling Pharmceuticals & Medical Supplies, Thimphu, Bhutan