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S.No.Brand NameGeneric NamePrevious Registration Number ( Before Renewal)Registration Number( Current )Approval DateManufacturerPack SizePack TypeValidityMAH in Bhutan
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1Bioline™ HCV(02FK10)HCV Rapid Test KitBHU-DRA-MD-01BHU-DRA-MD-2131-May-21Abbott Diagnostics Korea Inc.30 test per kitAluminum pouch in carton box31-May-24Wamling Pharmceuticals & Medical Supplies, Thimphu, Bhutan
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2Bioline™ Malaria Ag P.F/Pan (05FK60)Malaria Ag P.f/Pan Rapid Test KitBHU-DRA-MD-02BHU-DRA-MD-2231-May-21Abbott Diagnostics Korea Inc.25 test per kitAluminum pouch in carton box31-May-24Wamling Pharmceuticals & Medical Supplies, Thimphu, Bhutan
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3SD Bioline Malaria Ag P.F/PV(05FK30)Malaria Ag P.f/P.v Rapid Test KitDeregisteredBHU-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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4Bioline™ HBsAg (01FK10)HBsAg Rapid Test KitBHU-DRA-MD-04BHU-DRA-MD-2531-May-21Abbott Diagnostics Korea Inc.30 test per kitAluminum pouch in carton box31-May-24Wamling Pharmceuticals & Medical Supplies, Thimphu, Bhutan
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5Bioline™ Syphilis 3.0 (06FK11)Syphilis 3.0 Rapid Test KitBHU-DRA-MD-05BHU-DRA-MD-2431-May-21Abbott Diagnostics Korea Inc.100 test per kitAluminum pouch in carton box31-May-24Wamling Pharmceuticals & Medical Supplies, Thimphu, Bhutan
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6Bioline™ HIV-1/2 3.0(O3FK10)HIV-1/2 3.0 Rapid Test KitBHU-DRA-MD-06BHU-DRA-MD-2331-May-21Abbott Diagnostics Korea Inc.30 test per kitAluminum pouch in carton box31-May-24Wamling Pharmceuticals & Medical Supplies, Thimphu, Bhutan
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7N/A
Syphilis RPR Test Kit ( REF 50001)
BHU-DRA-MD-07BHU-DRA-MD-2706-Dec-2021
HUMAN Gesellschaft für Biochemica
und Diagnostica mbH
100 testsCarton box6/12/24
Dzambala Pharmceuticals &
Medical Supplies, Thimphu, Bhutan
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8Abbott Determine HBsAg2(7D2943)Hepatitis B Surface antigen test kitDeregisteredBHU-DRA-MD-0816-Apr-19Abbott Diagnostics Medical Co., Ltd.
357 Matsuhidai, Matsudo-shi, Chiba, 279-2214, Japan
Tel +81473115750		10 test cards(100 tests)Aluminium coated plastic bag15-Apr-22Wamling Pharmceuticals & Medical Supplies, Thimphu, Bhutan
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9Abbott Determine HIV-1/2 (7D2343)HIV test kitDeregisteredBHU-DRA-MD-0916-Apr-19Abbott Diagnostics Medical Co., Ltd.
357 Matsuhidai, Matsudo-shi, Chiba, 279-2214, Japan
Tel +81473115750		10 test cards(100 tests)Aluminium coated plastic bag15-Apr-22Wamling Pharmceuticals & Medical Supplies, Thimphu, Bhutan
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10Abbott Determine SYPHILIS TP(7D2443)Syphilis Test kitDeregisteredBHU-DRA-MD-1016-Apr-19Abbott Diagnostics Medical Co., Ltd.
357 Matsuhidai, Matsudo-shi, Chiba, 279-2214, Japan
Tel +81473115750		10 test cards( 100 tests)Aluminium coated plastic bag15-Apr-22Wamling Pharmceuticals & Medical Supplies, Thimphu, Bhutan
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11Diagnostic kit for HIV (1+2) Antibody (Colloidal Gold) V2HIV 1+2 rapid test kitDeregisteredBHU-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
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12Bioline™ Ag P.f/P.v (05FK80)Malaria Test KitDeregisteredBHU-DRA-MD-1224-Apr-19Abbott Diagnostics Korea Inc.25 test/kitAluminium coated plastic pouch23-Apr-22Wamling Pharmceuticals & Medical Supplies, Thimphu, Bhutan
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13CareStart™ Malaria HRP2/pLDH (Pf/Pv) COMBO RDTMalaria Pf/Pv (HRP2/pLDH) Ag Combo RDTDeregisteredBHU-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
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14CareStart™ Malaria pLDH (PAN) Ag RDTMalaria PAN (pLDH) Ag RDTDeregisteredBHU-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
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15OnSite® Syphilis Ab Rapid TestSyphilis Rapid Test KitDeregisteredBHU-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
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16Abbott Determine
HIV EARLY DETECT(7D2843)		HIV Test KitDeregisteredBHU-DRA-MD-1627-May-19Abbott Diagnostics Medical Co., Ltd.
357 Matsuhidai, Matsudo-shi, Chiba, 279-2214, Japan
Tel +81473115750		10 test cars(100 tests)Aluminium coated plastic pouch26-May-2022Wamling Pharmceuticals & Medical Supplies, Thimphu, Bhutan
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17ORA QUICK HIV SELF TESTHIV SELF-TESTN.ABHU-DRA-MD-1713-April-2021Manufactured in Thailand for
Orasure Technologies, Inc
250 kits in a box( 5x4-1001)
Aluminium pouch in carton box.13/04/2024Wamling Pharmceuticals &
Medical Supplies,
Thimphu, Bhutan
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18ORA QUICK HIV SELF TESTHIV SELF-TESTN.ABHU-DRA-MD-1813-April-2021Manufactured in Thailand for
Orasure Technologies, Inc
200 kits in a box( 5x4-2001)
Aluminium pouch in carton box.13/04/2024Wamling Pharmceuticals
& Medical Supplies,
Thimphu, Bhutan
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19InTec One step Anti-HIV (1 &2) TestHIV RTDN.ABHU-DRA-MD-1927-April-2021InTec Products, Inc, China40 Kits in a boxAluminium pouch in carton box.27/04/2024Norling Pharmacy, Thimphu Bhutan
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20InTec Anti-HCV TestHCV RTDN.ABHU-DRA-MD-2027-April-2021InTec Products, Inc, China40 Kits in a boxAluminium pouch in carton box.27/04/2024Norling Pharmacy, Thimphu Bhutan
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21Bioline HIV/Syphilis DuoHIV/Syphilis Test KitN.ABHU-DRA-MD-2609-July-2021Abbott Diagnostics Korea Inc.25 Kits in a boxAluminium pouch in carton box.09/07/2024Wamling Pharmceuticals
& Medical Supplies,
Thimphu, Bhutan
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23Bioline Malaria Ag P.f/P.v (05FK80)Malaria Test KitN.ABHU-DRA-MD-2806-July-2022Abbott Diagnostics Korea Inc.25 kits in a boxAluminium pouch in carton box.05/07/2025Wamling Pharmceuticals
& Medical Supplies,
Thimphu, Bhutan
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