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WHO list of prequalified in vitro diagnostic productsRoW: Rest of the world. Regulatory version applied to products not approved by stringent/mature NRAs or not regulatedLast update: 20 December 2021Year prequalifiedType of assayRegulatoryversionProduct nameProduct code(s)CE-markCE-mark2021HIV NATcobas HIV-1 Quantitative nucleic acid testfor use on the cobas4800 0 ;069795481902021HCV NATcobas HCV (Quantitative nucleic acid testfor use on cobas 6800/8800 Systems)6997732190RoWManufacturerManufacturing site(s)PackagingRoche Diagnostics GmbHSandhofer Strasse 116, Mannheim,68305 Germany120 T/kit;10 Sets;240 T/kit;960 T/kit;240 T/kit;960 T/kit;240 T/kit;240 T/kit;960 T/kitRoche Diagnostics GmbHSandhofer Strasse 116, Mannheim,68305 Germany96 T/kitsite 1: A1-302, GIDC, Sarigam 396155, Valsad, Gujarat, India .Premier Medical Corporation Privatesite 2: 32-35A, Shree Ganesh Industrial Estate, Kachigam,LimitedNani Daman,Daman 396215, India.25 T/kit50 T/kit100 T/kit2021Syphilis RDTFirst Response Syphilis Anti-TP Card TestPI08FRC25,PI08FRC50PI08FRC1002020HIV NATcobas HIV-1 Quantitative nucleic acid testfor use onthe cobas 6800/8800 Systems07000995190CE-markRoche Diagnostics GmbH,Sandhofer Strasse 116, Mannheim,68305 Germany96 T/kit2020HIV RDTMERISCREEN HIV 1-2 WBHVWRPD-01HVWRPD-02CE-markMeril Diagnostics Pvt. Ltd.Second Floor, D1-D3, Meril Park, Survey No135/2/B & 174/2, Muktanand Marg, Chala, Vapi, 396191,India30 T/kit40 T/kit2020Malaria RDTParacheck Pf - Rapid Test for P.Falciparum MalariaDevice (Ver. rchid BiomedicalSystems – A Division of TulipDiagnostics (P) LtdPlot nos 88/89, Phase II C, Verna Industrial Estate, Verna,Goa, 403722, India5 T/kit10 T/kit25 T/kit100 T/kit2020Malaria RDTOne Step test for Malaria Pf/Pan AgMERISCREENMalaria Pf/Pan AgMHLRDP-02RoWMeril Diagnostics Pvt. LtdSecond Floor, D1-D3, Meril Park, Survey No 135/2/B &174/2, Muktanand Marg, Chala, Vapi, 396191, India30 T/kit2020CD4 TechnologiesVISITECT CD4 Advanced DiseaseOD376CE-markOmegaDiagnostics LtdOmega Diagnostics Ltd located at Hillfoots Business,Village, Alva, FK12 5DQ United Kingdom.25 T/kit2020HIV RDTSTANDARD Q HIV 1/2 Ab 3-Line Test09HIV30D;09HIV30DMRoWSD Biosensor, Inc74, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu,Cheongju-si, Chungcheongbuk-do,28161, Republic of Korea25 T/kit;25 T/kit2020Malaria RDTparascreen - Rapid test for Malaria rkZephyr Biomedicals – A Division ofTulipDiagnostics (P) Ltd.M46-47, Phase III B, Verna, Goa, 403722, India10 T/kit25 T/kit50 T/kit100 T/kit2020Malaria RDTFalciVax - Rapid test for Malaria kZephyr Biomedicals – A Division ofTulipDiagnostics (P) Ltd.M46-47, Phase III B, Verna, Goa, 403722, India10 T/kit25 T/kit50 T/kit100 T/kit2020HIV/Syp RDTSTANDARD Q HIV/Syphilis Combo Test09HIV20DRoWSD Biosensor, Inc74, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu,Cheongju-si, Chungcheongbuk-do,28161, Republic of Korea25 T/kit
WHO list of prequalified in vitro diagnostic productsRoW: Rest of the world. Regulatory version applied to products not approved by stringent/mature NRAs or not regulatedLast update: 20 December 2021Year prequalifiedType of assayProduct nameProduct code(s)RegulatoryversionManufacturer2020HCV NATGenedrive HCV ID KitID-HCV-03CE-markGenedrive Diagnostics Ltd2020HCV NATAlinity m HCV08N50-090;08N50-080;08N50-070CE-markAbbott Molecular Inc2020Malaria RDTSTANDARD Q Malaria P.f/P.v Ag Test09MAL20DCE-markSD Biosensor, Inc.74, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu,Cheongju-si, Chungcheongbuk-do,28161, Republic of Korea25 T/kit2020Malaria RDTSTANDARD Q Malaria P.f Pan Ag Test09MAL30DCE-markSD Biosensor, Inc.74, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu,Cheongju-si, Chungcheongbuk-do,28161, Republic of Korea25 T/kit2020Malaria RDTSTANDARD Q Malaria P.f Ag Test09MAL10DCE-markSD Biosensor, Inc.74, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu,Cheongju-si, Chungcheongbuk-do,28161, Republic of Korea25 T/kit2020HCV RDTSTANDARD Q HCV Ab Test09HCV10DRoWSD Biosensor, Inc.74, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu,Cheongju-si, Chungcheongbuk-do,28161, Republic of Korea25 T/kit2020HCV EIAMonolisa HCV Ag-Ab ULTRA V272561 and 72562CE-markBio-Rad3, bd Raymond Poincaré, 92430, Marne La Coquette,France and Route de Cassel, 59114, Steenvoorde, France96 T/kit480 T/kit2019HCV NAT*Abbott RealTime HCV4J86-90; 4J86-80; and4J86-70CE-markAbbott Molecular Inc1300 East Touhy Avenue, Des Plaines, IL 60018USA96 T/kit2019HIV RDT for self-testingSURE CHECK HIV Self-Test60-9508-0RoWChembioDiagnostic Systems, Inc3661 Horseblock Road, Medford, NY 11763USA1 T/kit2019HPVVirological Technologies*Abbott RealTime High Risk HPV02N09-092; and02N09-080CE-markAbbott GmbHMax-Planck-Ring 2, Wiesbaden, 65205, Germany96 T/ kit*First Response HIV 1-2.O Card test(Version C50;PI05FRC60;PI05FRC1002019HIV RDTRoWManufacturing site(s)48 Grafton Street, Manchester, UK1300 East Touhy Avenue, Des Plaines, IL 60018USAPremier Medical Corporation PrivateA1-302, GIDC, Sarigam, IndiaLimitedPackaging10 T/kit4 trays of 48 T/kit12 tubes of each control4 tubes x 1.95 mL5 T/kit10 T/kit25 T/kit30 T/kit50 T/kit60 T/kit100 T/kit
WHO list of prequalified in vitro diagnostic productsRoW: Rest of the world. Regulatory version applied to products not approved by stringent/mature NRAs or not regulatedLast update: 20 December 2021Year prequalifiedType of assayProduct name2019HBsAg RDT*Determine HBsAg 22019HCV EIAARCHITECT HCV Ag assay2019HIV RDT for self-testing*Mylan HIV Self Test2019HIV/Syp RDT*First Response HIV1 2/Syphilis ComboCard Test2019HIV RDT*ONE STEP Anti‐HIV (1&2) Test2019HCV RDTRapid Anti‐HCV Test2019Malaria RDTAdvDx Malaria Pf Rapid Malaria AgDetection TestProduct code(s)7D2942;7D2943;7D2943 SET6L47-29; 6L47-11;6L47-02; and E-markAlere Medical Co. LtdCE-markDenka Seiken Co., LTD, KagamidaFactoryRoWRoWAtomo Diagnostics Pvty. LtdManufacturing site(s)Packaging357 Matsuhidai, Matsudo-shi, 270-2214,Chiba-ken, Japan20 T/kit100 T/kit100 T/kitStreet 1359-1, Kagamida, Kigoshi, Gosen-shi, Niigata,Japan100 T/kitSite 1: AtomoDiagnostics Pty Ltd atLevel 2, 701-703 Parramatta Road,Leichardt 2040 NSW, AustraliaSite 2: Lateral Flow Laboratories (LFL) at Unit 1 & 2,Greenwich Place, Capricorn Crescent, CapricornTechnology Park, Muizenberg,7945, South AfricaPremier Medical Corporation PrivateSarigam, Gujarat, IndiaLimitedRoWInTec PRODUCTS, INC308, Wengjiao Rd, Xinyang IND. AREA, Haicang, Xiamen,361022, oWInTec PRODUCTS, INC308, Wengjiao Rd, Xinyang IND. AREA, Haicang, Xiamen,361022, China00-DKM-RK-MALADX-004-025RoWAdvy Chemical Pvt Ltd.,Plot No.A-334,336,338 & A-337 & 339Road no. 25 & 26, Wagle industial EstateThane 400 604India05FK140Malaria RDT*NxTek Eliminate Malaria Pf05FK142CE-markAbbott Diagnostics Korea Incsite 1: 46, Hagal-ro 15 beongil,Giheung-gu, Yongin-si, Gyeonggi-do 17099, Republic ofKoreasite 2: 65, Borahagal-ro,Giheung-gu, Yongin-si, Gyeonggi-do 17099, Republic ofKorea05FK1432019HIV NAT*m-PIMA HIV-1/2 VL27015-W50First Response Malaria Antigen P40 T/kit25 T/kit40 T/kit40 T/kit40 T/kit25 T/kit40 T/kit25 T/kit25T/Kit1T/kit x 25 each1T/kit x 25 eachRoWAbbott Rapid Diagnostics Jena GmbH Orlaweg 1, D-07743 Jena, GermanyPI13FRC25sPI13FRC10s25 T/kit30 T/kit50 T/kit60 T/kit100 T/kit25T/Kit05FK14120191 T/kit;1 T/kit;1 T/kit;1 T/kit.50 cartridges/kit25 single kitsite 1: A1-302, GIDC, Sarigam 396 155, Valsad, Gujarat,India;10 single kit
WHO list of prequalified in vitro diagnostic productsRoW: Rest of the world. Regulatory version applied to products not approved by stringent/mature NRAs or not regulatedLast update: 20 December 2021Year prequalified20182018Type of assayProduct nameMalaria RDTFirst Response Malaria Antigen P.falciparum (HRP2) Card TestMalaria RDTFirst Response Malaria Ag. pLDH/HRP2Combo Card TestProduct emier Medical Corporation LimitedMalaria RDT25 multi kitPI13FRC3030 multi kit10 single kitPI16FRC25sRoWPremier Medical Corporation Limitedsite 1: A1-302, GIDC, Sarigam 396 155, Valsad, Gujarat,India;site 2: 32-35A, Shree Ganesh Industrial Estate, Kachigam,Nani Daman, Daman 396215, India25 single kit25 multi kitPI16FRC3030 multi kitPI19FRC10s10 single t Response Malaria Ag. P.f. / P.v. CardTestManufacturing site(s)India;site 2: 32-35A, Shree Ganesh Industrial Estate, Kachigam,Nani Daman, Daman 396215, IndiaPI19FRC30RoWsite 1: A1-302, GIDC, Sarigam 396 155, Valsad, Gujarat,India;Premier Medical Corporation Limitedsite 2: 32-35A, Shree Ganesh Industrial Estate, Kachigam,Nani Daman, Daman 396215, India25 single test30 multi test25 multi testPI19FRC252018Malaria RDT*Bioline Malaria Ag P.f/P.f/P.v05FK120;05FK123CE-markAbbott Diagnostics Korea Inc2018HIV RDT for self-testing*INSTI HIV Self Test90-1071RoWbioLytical Laboratories Inc.RoWGuangzhou Wondfo Biotech Co., Ltd2018HIV RDT*One Step HIV1/2 WholeBlood/Serum/Plasma 51 ,W006-P00522018Malaria RDT*One Step test for Malaria Pf/Pv AgMERISCREEN Malaria Pf/Pv 2018CD4 Technologies*CyFlow Counter System with CD4 easycount kit and CD4% easy count kitCY-S-3022; 05-8401; and 05-84052018HPVVirological Technologiescare HPV Test2018HCV EIAINNOTEST HCV Ab IV65 Borahagal-ro, Giheung-gu, Yongin-si, Geonggi-do,South KoreaRichmond, British Columbia, Canada25T/kit;1T/kit1T/kit8 Lizhishan Road, Science City, Luogang District,Guangzhou, 510663, Republic of it;40T/kit;40T/kit;40T/kit;40T/kitMeril Diagnostics Pvt. Ltd.D1-D3, Meril Park, Survey No. 135/2/B & 174/2,Muktanand Marg, Chala, Vapi 396191, Gujarat, India30T/kit;25T/kit;50T/kit;10 T/kit.CE-markedSysmex Partec GmbHsite 1: Arndtstr. 11a-b, 02826 Görlitz, Germany; andsite 2: Exbio Praha a.s., Nad Safinou II 341, 252 50Vestec, Czech Republic100 T/kit614015CE-markQIAGEN GmBHsite 1: QIAGEN Sciences, Germantown, 20874, UnitedStatessite 2: QIAGEN Shenzhen Co., Shenzhen China96 T/kit80068;80330CE-markFujirebio Europe NVGhent, Belgium192T/kit480T/kit
WHO list of prequalified in vitro diagnostic productsRoW: Rest of the world. Regulatory version applied to products not approved by stringent/mature NRAs or not regulatedLast update: 20 December 2021Year prequalifiedType of assayProduct nameProduct code(s)RegulatoryversionManufacturer2017HBsAg RDT*Bioline HBsAg WB01FK10WRoWAbbott Diagnostics Korea Inc2017HIV RDTGenie Fast HIV 1/272327;72347;72330CE-markBio-Rad2017Virological TechnologiesXpert HPVGXHPV-CE-10CE-mark2017Virological Technologies*Aptima HIV-1 Quant Dx AssayPRD-03000 (PRD-03002, PRD-03001);303014; PRD-03003; and 303095Manufacturing site(s)PackagingGiheung-gu, Republic of Korea30T/kitMarne La Coquette, France25T/kit50T/kit50T/kitCepheid ABSolna, Sweden10T/kitCE-markHologic, Inc.San Diego, USA100T/kitRoWOraSure Technologies, Inc.site 1: Bethlehem, USAsite 2: Phetchabun, Thailandsite 3: Ayutthaya, Thailand50T/kit;250T/kit;110T/kit2017HIV RDT for self-testing*OraQuick HIV Self-Test5X4-1000;5X4-1001;5X4-2001;Country specific variations are documented through asuffix “###” to the product code onthe outer packaging (i.e. 5X4-1001.001, .002, ).2017Virological Technologies*Xpert HIV-1 Viral LoadGXHIV-VL-CE-10CE-markCepheid ABSolna, Sweden10T/kit2017HCV NAT*Xpert HCV Viral LoadGXHCV-VL-CE-10CE-markCepheid ABSolna, Sweden10T/kit2017HIV Confirmatory AssayGeenius HIV 1/2 Confirmatory Assay withGeenius HIV1/2 Confirmatory Controls72460; and 72329CE-markBio-RadMarnes-La-Coquette, France20T/kit2017HCV RDTOraQuick HCV Rapid Antibody Test Kit1001-0270;001-0274CE-markOraSure Technologies, Inc.Bethlehem, USA25T/kit;100T/kit2016HIV RDTDiagnostic kit for HIV (1 2) antibody(colloidal gold) V2R-401-50-C-2; KH-R-02; and A-GOLD-01RoW2016HCV RDT*Bioline HCV02FK10;02FK16;02FK17RoWAbbott Diagnostics Korea Inc2016HIV RDT*Determine HIV Early Detect7D2842;7D2843;7D2843SETRoWAlere Medical Co. Ltd.2016HIV NAT*Xpert HIV-1 Qual AssayGXHIV-QA-CE-10CE-markCepheid ABSolna, Sweden10 cartridges/kit and instrument2016HIV NAT*m-PIMA HIV-1/2 Detect270110050;270110010;270300001CE-markAlere Technologies GmbHJena, Germany50 cartridges/kit50 cartridges/kitInstrumentShanghai Kehua Bio-engineering Co.,Shanghai, PR ChinaLtdGiheung‐gu, Republic ofKoreaMatsudo-shi, Chiba-ken, 100T/kit
WHO list of prequalified in vitro diagnostic productsRoW: Rest of the world. Regulatory version applied to products not approved by stringent/mature NRAs or not regulatedLast update: 20 December 2021Year prequalifiedType of assayProduct nameProduct code(s)RegulatoryversionManufacturer2016HIV RDTDPP HIV 1/2 Assay65-9506-0RoWChembio Diagnostic Systems Inc.2016HIV RDT*OraQuick HIV 1/2Rapid Antibody raSure Technologies, Inc.2016HBsAg 55/1.2;В-1256/1.2;В-231/1.2CE-markRPC Diagnostics Systems2016HIV Confirmatory AssayMP Diagnostics HIV Blot 2.211030-018;11030-036CE-markMP Biomedicals Asia Pacific Pte.Ltd.2016HIV EIAAiD anti-HIV 1 2 ELISAWI-4396;WI-43480RoWRoWManufacturing site(s)Medford, NY, USAsite 1: Bethlehem, USAsite 2: Petchabun, Thailandsite 3: Ayutthaya, ThailandNizhniy Novgorod, RussiaSingapore, t500T/kit500T/kit96T/kit;192T/kit;480T/kit;96T/kit (for detection) or 48T/kit(for confirmation)200T/kit18T/kit;36T/kitBeijingWantai Biological Pharmacy Enterprise Beijing, ChinaCo.96T/kit;480T/kitBeijingWantai Biological Pharmacy Enterprise Beijing, ChinaCo.10T/kit10T/kit;50T/kit;50T/kit;10 T/kit;50 T/kit;10 T/kit;50 T/kit;10 T/kit;50 T/kit;10 T/kit;50 T/kit2016HIV RDT*Rapid Test for Antibody to HumanImmunodeficiency Virus (HIV) (ColloidalGold ;WJ-18S10E;WJ 18S50E2015CD4 TechnologiesAquios CL flow cytometerB30166; B39101; B39102; B25697; B25698; B23536;B23538; B23533; B23534; B23535; B25700; and B23502CE-markBeckman Coulter Life Sciencessite 1: Miami, FL, USA (instrument site)site 2: Hialeah, FL, USA (reagent site)50T/kit2015HIV/Syp RDT*Bioline HIV/Syphilis Duo06FK30;06FK35RoWAbbott Diagnostics Korea IncGiheung-gu, Republic of Korea25T/kit;25T/kit*Bioline Malaria Ag 15Malaria RDTCE-markAbbott Diagnostics Korea IncGiheung-gu, Republic of Korea25T/kit;25T/kit1T/kit x25 each1T/kit x25 each10T/kit25T/kit
WHO list of prequalified in vitro diagnostic productsRoW: Rest of the world. Regulatory version applied to products not approved by stringent/mature NRAs or not regulatedLast update: 20 December 2021Year prequalifiedType of assayProduct nameProduct code(s)RegulatoryversionManufacturer2015Malaria RDT*Bioline Malaria Ag P.f bott Diagnostics Korea Inc2015HCV EIAINNO-LIA HCV Score80538CE-markFujirebio Europe NV2015HIV EIA*DS-EIA-HIV-AGAB-SCREENCE-markRPC Diagnostics Systems2015Malaria RDT**CareStart Malaria HRP2/pLDH acturing site(s)Giheung-gu, Republic of KoreaZwijnaarde, BelgiumNizhniy Novgorod, RussiaPackaging25T/kit;1T/kit x25 each25T/kit1T/kit x 25 each20T/kit96T/1 plate;192T/2 plates;480 T/5 plates25T/kit; 50T/kit;multi kit (product codes: RMRM-02571; RMRM-02571CB;RMRM-02571RB; RMRM-02571RI; RMRM-05071;RMRM-05071CB; RMRM-05071RB and RMRM-05071RI)RoWAccess Bio, Inc.Somerset NJ, USA25T/kit; 40T/kit;single kit (product codes: RMRU-02571; RMRU-02571CB;RMRU-02571RB; RMRU-02571RI; RMRU-04071; RMRU04071CB; RMRU-04071RB and RMRU-04071RI)25T/kit; 50T/kit;multi kit (product codes: RMOM-02571; RMOM02571CB; RMOM-02571RB; RMOM-02571RI; RMOM05071; RMOM-05071CB; RMOM-05071RB and RMOM05071RI)2015Malaria RDT**CareStart Malaria HRP2 (Pf)RoWAccess Bio, Inc.Somerset NJ, USA25T/kit; 40T/kit;single kit (product codes: RMOU-02571; RMOU-02571CB;RMOU-02571RB; RMOU-02571RI; RMOU-05071; RMOU05071CB; RMOU-05071RB and RMOU-05071RI)multi kit (product codes: RMVM-02571; RMVM02571CB; RMVM-02571RB; RMVM-02571RI; RMVM05071; RMVM-05071CB; RMVM-05071RB and RMVM05071RI)2015Malaria RDT**CareStart Malaria HRP2/pLDH (Pf/Pv)COMBOsingle kit (product codes: RMVU-02571; RMVU-02571CB;RMVU-02571RB; RMVU-02571RI; RMVU-05071; RMVU05071CB; RMVU-05071RB and RMVU-05071RI)25T/kit; 50T/kitRoWAccess Bio, Inc.Somerset NJ, USA25T/kit; 40T/kit25T/kit; 50T/kitmulti kit (product codes: RMPM-02571; RMPM-02571CB;RMPM-02571RB; RMPM-02571RI; RMPM-05071; RMPM05071CB; RMPM-05071RB and RMPM-05071RI)2015Malaria RDT**CareStart Malaria HRP2/pLDH (Pf)RoWAccess Bio, Inc.Somerset NJ, USA
WHO list of prequalified in vitro diagnostic productsRoW: Rest of the world. Regulatory version applied to products not approved by stringent/mature NRAs or not regulatedLast update: 20 December 2021Year prequalifiedType of assayProduct nameProduct code(s)/p2015Malaria RDT( )RegulatoryversionManufacturer,Manufacturing site(s)Packaging,single kit (product codes: RMPU-02571; RMPU-02571CB;RMPU-02571RB; RMPU-02571RI; RMPU-05071; RMPU05071CB; RMPU-05071RB and RMPU-05071RI)25T/kit; 40T/kitmulti kit (product codes: RMNM-02571; RMNM02571CB; RMNM-02571RB; RMNM-02571RI; RMNM05071; RMNM-05071CB; RMNM-05071RB and RMNM05071RI)25T/kit; 50T/kit**CareStart Malaria pLDH (PAN)RoWAccess Bio, Inc.Somerset NJ, USAsingle kit (product codes: RMNU-02571; RMNU-02571CB;RMNU-02571RB; RMNU-02571RI; RMNU-05071; RMNU05071CB; RMNU-05071RB and RMNU-05071RI)25T/kit; 40T/kit2015HIV Confirmatory AssayINNO-Lia HIV I/II Score80540CE-markFujirebio Europe NV2015HIV EIAMurex HIV Ag/Ab Combination7G79-09 (GE41, 96 wells); and 7G79-11 (GE42, 480 wells)CE-markDiaSorin S.p.A UK Branch2014Virological Technologies*COBAS AmpliPrep/COBAS TaqMan HIV-1Qualitative Test, version 2.0 (TaqMan 48)06693083190; 03051315001; 03279332001;03587797190; 06989861190; 05807875001;03516440001; and 28127387001CE-markRoche Molecular Systems, Inc.2014Virological Technologies*COBAS AmpliPrep/COBAS TaqMan HIV-1Qualitative Test, version 2.0 (TaqMan 96)06693083190; 03587797190; 06989861190;03051315001; 03121453001; 28127387001;05807875001; and 03516440001CE-markRoche Diagnostics GmbH2014HIV RDT*SURE CHECK HIV 1/2 AssayHIV201 (60-9527-0),RoWChembio Diagnostic Systems Inc.2014HBsAg EIAMurex HBsAg Version 3 with MurexHBsAg Confirmatory Version 39F80-01;9F80-05;2G27-01CE-markDiaSorin S.p.A UK Branch2014Malaria RDTParaHIT f Ver. 1.0 Rapid Test forP.falciparum Malaria Y Healthcare Pvt. Ltd.2014CD4 Technologies*BD FACSPresto Near-Patient CD4Counter with BD CD4%CD4/Hb Cartridgeand BD FACSPresto Cartridges Kit651000;657681;655495CE-mark2014HIV RDT*ABON HIV 1/2/O Tri-Line HumanImmunodeficiency Virus Rapid Test RoWGhent, BelgiumDartford, UK20T/kit96T/kit; 480T/kitBranchburg, New Jersey, USA48T/kitMannheim, Germany48T/kitMedford, NY, USA25T/kitDartford, UK96T/kit;480T/kit50T/kitSachin (Surat), India10T/kit;25T/kit;50T/kitBecton, Dickinson and Company, BD San Jose, California, USABiosciencesSingapore, SingaporeABON Biopharm (Hangzhou) Co. Ltd. Hangzhou, PR China651000: instrument657681: catridge (100/box)655495: pipette (100/box)40T/kit;40T/kit;40T/kit;5T/kit
WHO list of prequalified in vitro diagnostic productsRoW: Rest of the world. Regulatory version applied to products not approved by stringent/mature NRAs or not regulatedLast update: 20 December 2021Year prequalified2013Type of assayHIV RDTProduct name*INSTI HIV-1/HIV-2 Antibody 405FK60;05FK61;05FK62;05FK63;05FK672013Malaria RDT*Bioline Malaria Ag P.f/Pan2013Virological Technologies*Abbott RealTime HIV-1 Qualitative(Manual)2013Virological Technologies*Abbott RealTime HIV-1 Qualitative(m 2000sp)2013HIV RDT*Bioline HIV-1/2 3.02013HIV EIA*Genscreen ULTRA HIV Ag-AbRegulatoryversionProduct code(s)RoWManufacturerBioLytical Laboratories, Inc.Giheung-gu, Republic of KoreaAbbott Molecular Inc.Des Plaines, IL, USA96T/kit;4x24T packCE-markAbbott Molecular Inc.Des Plaines, IL, USA96T/kit;4x24T packRoWAbbott Diagnostics Korea IncCE-markBio-RadAbbott Diagnostics Korea Inc4N66-90; 4N66-80; 6K12-24; 9K15-01; 4N66-01; and4N66-66 (optional)CE-mark4N66-90; 9K14-02; 9K15-01; 4N66-80; 4N66-01; 6K1224; and 4N66-66 (optional)72386; and 502N1206502-100;1206502E1206502-C100Richmond, British Columbia, CanadaPackaging24T/kit without support material;24T/kit with support materials;48T/kit without support material;48T/kit with support materials;48T/kit with pipettesbut no lancet, no alcoholswabs);48T/kit with no support CE-mark03FK10;03FK16;03FK17Manufacturing site(s)RoWTrinity Biotech Manufacturing Ltd.Giheung-gu, Republic of KoreaMarnes La Coquette, FranceBray, Ireland30T/kit;25T/kit;25T/kit96T/kit; 20T/kit;20T/kit;100T/kit2012HIV RDT*Uni-Gold HIV2012CD4 Technologies*Pima CD4 Test260100025 and 260300003; 260100100; and 260300003CE-markAbbott Rapid Diagnostics Jena GmbH Orlaweg 1, D-07743 Jena, Germany2012CD4 TechnologiesBD FACSCount Instrument System withFACSCount Control Kit and BD FACSCountReagent Kit (Absolute CD4 , CD8 , andCD3 Counts)337858;340166;340167CE-markBecton, Dickinson and Company, BDSan Jose, CA, USABiosciences337858: instrument system340166: 25T /kit340167: 50T/kit2012CD4 TechnologiesBD FACSCount Instrument System withFACSCount Control Kit and BD FACSCountCD4 Reagent Kit (Absolute andPercentage CD4 Counts)337858;340166;339010CE-markBecton, Dickinson and Company, BD San Jose, CA, USA andBiosciencesCayey, Puerto Rico337858: instrument system340166: 25T/kit339010: 50T/kit25 cartridges/kit and instrument;100 cartridges/kit and instrument
WHO list of prequalified in vitro diagnostic productsRoW: Rest of the world. Regulatory version applied to products not approved by stringent/mature NRAs or not regulatedLast update: 20 December 2021Year prequalifiedType of assayProduct nameProduct code(s)RegulatoryversionManufacturerManufacturing site(s)Packaging2012Virological Technologies*COBAS AmpliPrep/COBAS TaqMan HIV-1Test, version 2.0 (TaqMan 48)05212294190; 03587797190; 03121453001;03051315001 or 05807875001 and 07963084190.Optional: 05527503001; 28127387001CE-markRoche Diagnostics GmbHMannheim, Germany05212294190: 48T/kit03587797190: 5.1 liters2012Virological Technologies*COBAS AmpliPrep/COBAS TaqMan HIV-1Test, version 2.0 (TaqMan 96)05212294190; 03587797190; 03279332001;03051315001; 07347308001 or 05807875001 and07963084190.Optional: 05527503001; 28127387001CE-markRoche Molecular Systems, Inc.Branchburg, NJ, USA05212294190: 48T/kit03587797190: 5.1 liters2012HIV RDTHIV 1/2 STAT-PAKHIV101RoWChembio Diagnostic Systems Inc.280140; 280130; 280131; 280132; 280133; 280134;285056; 200309; and 285033CE-markbioMérieux SAMarcy L’Etoile, France280130, 280131, 280132,280133 and 280134: 4x1L285033: 48 T/kitMarcy L’Etoile, France200293 and 200292: 48T/kit, 285033: 48 T/kitMedford, NY, USA20T/kit2011Virological Technologies NucliSENS EasyQ HIV-1 v2.0 (Automated)2011Virological TechnologiesNucliSENS EasyQ HIV-1 v2.0 (SemiAutomated)200305; 200293; 200292; 285056; 200309; and 285033CE-markbioMérieux SA2011HIV RDT* Determine HIV-1/27D2342;7D2343;7D2343SETand 7D2343SETS.RoWAbbott Diagnostics Medical Co., Ltd2011Virological Technologies*Abbott RealTime HIV-1 (Manual)2G31 (2G31-90, 2G31-80, 2G31-70); 2G31-66; 1L68-09;9K15-01; 04J70-24; and 04J71-93CE-markAbbott Molecular Inc.Des Plaines, IL, USA2G31-90: 96T/kit (4x24T);2G31-80: 8 runs;2G31-70: 4 calibration runs (1/6 months);04J70-24: 96T/kit2011Virological Technologies*Abbott RealTime HIV-1 (m 2000sp)2G31 (2G31-90 or 2G31-010, 2G31-80, 2G31-70); 2G3166; 1L68-09; 9K15-01; 04J70-24; 04J71-93; and 9K14-02CE-markAbbott Molecular Inc.Des Plaines, IL, USA2G31-90: 96T/kit (4x24T) or 2G31-010 96T/kit (4x24T);2G31-80: 8 runs; 2G31-70: 4 calibration runs (1/6 months);04J70-24: 96T/kit2011Virological Technologies*Abbott RealTim e HIV-1 (m 24sp)3N06-01, 2G31(2G31-90, 2G31-80, 2G31-70); 2G31-66;1L68-09; 9K15-01; 04J70-24;and 04J71-93CE-markAbbott Molecular Inc.Des Plaines, IL, USA2G31-90: 96T/kit (4x24T);2G31-80: 8 runs;2G31-70: 4 calibration runs (1/6 months);04J70-24: 96T/kit*Bioline Malaria Ag P.f05FK50;05FK51;05FK52;05FK532010Malaria RDT* Public report was amended, please refer to public report for detailed amendments .** These products are subject to a WHO Notice of Concern: https://www.who.int/diagnostics laboratory/procurement/complaints/en/.End of documentCE-markAbbott Diagnostics Korea IncMatsudo-shi, Chiba-ken, JapanGiheung-ku, Republic of /kit;1T/kit x 25 each;1T/kit x 25 each.
cobas HIV-1 Quantitative nucleic acid test for use on the cobas 6800/8800 Systems 07000995190 CE-mark: Roche Diagnostics GmbH, Sandhofer Strasse 116, Mannheim, 68305 Germany: 96 T/kit 2020: HIV RDT MERISCREEN HIV 1-2 WB: HVWRPD-01 HVWRPD-02 CE-mark: Meril Diagnos
