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S.No. | Brand Name | Generic Name | Previous Registration Number ( Before Renewal) | Registration Number( Current ) | Approval Date | Manufacturer | Pack Size | Pack Type | Validity | MAH in Bhutan |
---|---|---|---|---|---|---|---|---|---|---|
1 | Biolineâ„¢ HCV(02FK10) | HCV Rapid Test Kit | BHU-DRA-MD-01 | BHU-DRA-MD-21 | 31-May-21 | Abbott Diagnostics Korea Inc. | 30 test per kit | Aluminum pouch in carton box | 31-May-24 | Wamling Pharmceuticals & Medical Supplies, Thimphu, Bhutan |
2 | Biolineâ„¢ Malaria Ag P.F/Pan (05FK60) | Malaria Ag P.f/Pan Rapid Test Kit | BHU-DRA-MD-02 | BHU-DRA-MD-22 | 31-May-21 | Abbott Diagnostics Korea Inc. | 25 test per kit | Aluminum pouch in carton box | 31-May-24 | Wamling Pharmceuticals & Medical Supplies, Thimphu, Bhutan |
3 | SD Bioline Malaria Ag P.F/PV(05FK30) | Malaria Ag P.f/P.v Rapid Test Kit | Deregistered | BHU-DRA-MD-03 | 31-Jul-18 | Standard Diagnostics Inc, 65, Borahagal-ro, Giheung-gu, Yongin-si, Gyeonggi-do, South Korea | 30 test per kit | Foil pouch packed in carton box | 30-Jul-21 | Wamling Pharmceuticals & Medical Supplies, Thimphu, Bhutan |
4 | Biolineâ„¢ HBsAg (01FK10) | HBsAg Rapid Test Kit | BHU-DRA-MD-04 | BHU-DRA-MD-25 | 31-May-21 | Abbott Diagnostics Korea Inc. | 30 test per kit | Aluminum pouch in carton box | 31-May-24 | Wamling Pharmceuticals & Medical Supplies, Thimphu, Bhutan |
5 | Biolineâ„¢ Syphilis 3.0 (06FK11) | Syphilis 3.0 Rapid Test Kit | BHU-DRA-MD-05 | BHU-DRA-MD-24 | 31-May-21 | Abbott Diagnostics Korea Inc. | 100 test per kit | Aluminum pouch in carton box | 31-May-24 | Wamling Pharmceuticals & Medical Supplies, Thimphu, Bhutan |
6 | Biolineâ„¢ HIV-1/2 3.0(O3FK10) | HIV-1/2 3.0 Rapid Test Kit | BHU-DRA-MD-06 | BHU-DRA-MD-23 | 31-May-21 | Abbott Diagnostics Korea Inc. | 30 test per kit | Aluminum pouch in carton box | 31-May-24 | Wamling Pharmceuticals & Medical Supplies, Thimphu, Bhutan |
7 | N/A | Syphilis RPR Test Kit ( REF 50001) | BHU-DRA-MD-07 | BHU-DRA-MD-27 | 06-Dec-2021 | HUMAN Gesellschaft für Biochemica und Diagnostica mbH | 100 tests | Carton box | 6/12/24 | Dzambala Pharmceuticals & Medical Supplies, Thimphu, Bhutan |
8 | Abbott Determine HBsAg2(7D2943) | Hepatitis B Surface antigen test kit | Deregistered | BHU-DRA-MD-08 | 16-Apr-19 | Abbott Diagnostics Medical Co., Ltd. 357 Matsuhidai, Matsudo-shi, Chiba, 279-2214, Japan Tel +81473115750 | 10 test cards(100 tests) | Aluminium coated plastic bag | 15-Apr-22 | Wamling Pharmceuticals & Medical Supplies, Thimphu, Bhutan |
9 | Abbott Determine HIV-1/2 (7D2343) | HIV test kit | Deregistered | BHU-DRA-MD-09 | 16-Apr-19 | Abbott Diagnostics Medical Co., Ltd. 357 Matsuhidai, Matsudo-shi, Chiba, 279-2214, Japan Tel +81473115750 | 10 test cards(100 tests) | Aluminium coated plastic bag | 15-Apr-22 | Wamling Pharmceuticals & Medical Supplies, Thimphu, Bhutan |
10 | Abbott Determine SYPHILIS TP(7D2443) | Syphilis Test kit | Deregistered | BHU-DRA-MD-10 | 16-Apr-19 | Abbott Diagnostics Medical Co., Ltd. 357 Matsuhidai, Matsudo-shi, Chiba, 279-2214, Japan Tel +81473115750 | 10 test cards( 100 tests) | Aluminium coated plastic bag | 15-Apr-22 | Wamling Pharmceuticals & Medical Supplies, Thimphu, Bhutan |
11 | Diagnostic kit for HIV (1+2) Antibody (Colloidal Gold) V2 | HIV 1+2 rapid test kit | Deregistered | BHU-DRA-MD-11 | 16-Apr-19 | Shanghai Kehua Bio-engineering Co., Ltd, 1189 North Qinzhou Road, Shanghai, P.R.China | 50 test casettes/kit | Aluminium coated plastic pouch | 15-Apr-22 | Norling Pharmceuticals & Medical Supplies, Thimphu, Bhutan |
12 | Biolineâ„¢ Ag P.f/P.v (05FK80) | Malaria Test Kit | Deregistered | BHU-DRA-MD-12 | 24-Apr-19 | Abbott Diagnostics Korea Inc. | 25 test/kit | Aluminium coated plastic pouch | 23-Apr-22 | Wamling Pharmceuticals & Medical Supplies, Thimphu, Bhutan |
13 | CareStartâ„¢ Malaria HRP2/pLDH (Pf/Pv) COMBO RDT | Malaria Pf/Pv (HRP2/pLDH) Ag Combo RDT | Deregistered | BHU-DRA-MD-13 | 25-Apr-19 | Access Bio Inc. 65 Clyde Road, Suite A, Somerset NJ08873, U.S.A | 25 test/kit | Plastic packet | 24-Apr-22 | Norling Pharmceuticals & Medical Supplies, Thimphu, Bhutan |
14 | CareStartâ„¢ Malaria pLDH (PAN) Ag RDT | Malaria PAN (pLDH) Ag RDT | Deregistered | BHU-DRA-MD-14 | 25-Apr-19 | Access Bio Inc. 65 Clyde Road, Suite A, Somerset NJ08873, U.S.A | 25 test/kit | Plastic packet | 24-Apr-22 | Norling Pharmceuticals & Medical Supplies, Thimphu, Bhutan |
15 | OnSite® Syphilis Ab Rapid Test | Syphilis Rapid Test Kit | Deregistered | BHU-DRA-MD-15 | 25-Apr-19 | CKT Biotech, Inc. 13855 Stowe Drive, Poway, CA 92064 USA. | 100 test/kit | Plastic packet | 24-Apr-22 | Norling Pharmceuticals & Medical Supplies, Thimphu, Bhutan |
16 | Abbott Determine HIV EARLY DETECT(7D2843) | HIV Test Kit | Deregistered | BHU-DRA-MD-16 | 27-May-19 | Abbott Diagnostics Medical Co., Ltd. 357 Matsuhidai, Matsudo-shi, Chiba, 279-2214, Japan Tel +81473115750 | 10 test cars(100 tests) | Aluminium coated plastic pouch | 26-May-2022 | Wamling Pharmceuticals & Medical Supplies, Thimphu, Bhutan |
17 | ORA QUICK HIV SELF TEST | HIV SELF-TEST | N.A | BHU-DRA-MD-17 | 13-April-2021 | Manufactured in Thailand for Orasure Technologies, Inc | 250 kits in a box( 5x4-1001) | Aluminium pouch in carton box. | 13/04/2024 | Wamling Pharmceuticals & Medical Supplies, Thimphu, Bhutan |
18 | ORA QUICK HIV SELF TEST | HIV SELF-TEST | N.A | BHU-DRA-MD-18 | 13-April-2021 | Manufactured in Thailand for Orasure Technologies, Inc | 200 kits in a box( 5x4-2001) | Aluminium pouch in carton box. | 13/04/2024 | Wamling Pharmceuticals & Medical Supplies, Thimphu, Bhutan |
19 | InTec One step Anti-HIV (1 &2) Test | HIV RTD | N.A | BHU-DRA-MD-19 | 27-April-2021 | InTec Products, Inc, China | 40 Kits in a box | Aluminium pouch in carton box. | 27/04/2024 | Norling Pharmacy, Thimphu Bhutan |
20 | InTec Anti-HCV Test | HCV RTD | N.A | BHU-DRA-MD-20 | 27-April-2021 | InTec Products, Inc, China | 40 Kits in a box | Aluminium pouch in carton box. | 27/04/2024 | Norling Pharmacy, Thimphu Bhutan |
21 | Bioline HIV/Syphilis Duo | HIV/Syphilis Test Kit | N.A | BHU-DRA-MD-26 | 09-July-2021 | Abbott Diagnostics Korea Inc. | 25 Kits in a box | Aluminium pouch in carton box. | 09/07/2024 | Wamling Pharmceuticals & Medical Supplies, Thimphu, Bhutan |
23 | Bioline Malaria Ag P.f/P.v (05FK80) | Malaria Test Kit | N.A | BHU-DRA-MD-28 | 06-July-2022 | Abbott Diagnostics Korea Inc. | 25 kits in a box | Aluminium pouch in carton box. | 05/07/2025 | Wamling Pharmceuticals & Medical Supplies, Thimphu, Bhutan |