WHO list of prequalified in vitro diagnostic products
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1 2018 CD4 CyFlow Counter System with CD4 easy count kit and CD4% easy count kit CY-S-3022, , ed Sysmex Partec GmbH Arndtstr. 11a-b, Görlitz, Germany; and Exbio Praha a.s., Nad Safinou II 341, Vestec, Czech Republic 100 T/kit 2018 HBsAg RDT Vikia HBsAg biomérieux SA 376 Chemin de l Orme, Marcy l Etoile, France 25 T/kit 2018 HPV care HPV Test QIAGEN GmBH QIAGEN Sciences, Germantown, 20874, United States QIAGEN Shenzhen Co., Shenzhen China 96 T/kit 2018 CD4 Muse Auto CD4/CD4% kit MCA100101, MCA500101, MCA1XK101 EMD Millipore Corporation Temecula, California 92590, USA 100 T/kit; 500 T/kit; 1000 T/kit 2018 HCV EIA INNOTEST HCV Ab IV 80068, Fujirebio Europe NV Ghent, Belgium 192T/kit; 2017 HBsAg RDT SD BIOLINE HBsAg WB 01FK10W Giheung-gu, Republic of Korea 30T/kit 2017 HIV RDT Genie Fast HIV 1/ , 72347, Bio-Rad Marne La Coquette, France 2017 Xpert HPV GXHPV-CE-10 Cepheid AB Solna, Sweden 10T/kit 2017 Aptima HIV-1 Quant Dx Assay PRD (PRD-03002, PRD ), , PRD-03003, and Hologic, Inc. San Diego, USA 100T/kit HIV RDT for selftesting OraQuick HIV Self-Test 5X4-1000, 5X4-1001, 5X OraSure, Inc. Bethlehem, USA Xpert HIV-1 Viral Load GXHIV-VL-CE-10 Cepheid AB Solna, Sweden 10T/kit ; 2; 110T/kit
2 2017 HCV NAT Xpert HCV Viral Load GXHCV-VL-CE-10 Cepheid AB Solna, Sweden 10T/kit 2017 HIV Confirmatory Assay Geenius HIV 1/2 Confirmatory Assay with Geenius HIV1/2 Confirmatory Controls 72460, Bio-Rad Marnes-La-Coquette, France 20T/kit 2017 HCV RDT OraQuick HCV Rapid Antibody Test Kit , OraSure, Inc. Bethlehem, USA 100T/kit 2016 HIV RDT Diagnostic kit for HIV (1+2) antibody (colloidal gold) V2 R C-2, KH-R-02, A-GOLD- 01 Shanghai Kehua Bioengineering Co., Ltd Shanghai, PR China 2016 HCV RDT SD BIOLINE HCV 02FK10 Giheung-gu, Republic of Korea 30T/kit 2016 HBsAg EIA bioelisa HBsAg , Biokit S.A. Llicà d`amunt, Spain 2016 HIV RDT First Response HIV Card Test I05FRC100, I05FRC60, I05FRC30, I05FRC HIV RDT Alere HIV Combo 7D2842, 7D2843, 7D2843SET Premier Medical Corporation Alere Medical Co. Ltd. Nani Daman, Daman, India and Sarigam, Gujarat, India Matsudo-shi, Chiba-ken, Japan 2016 HIV NAT Xpert HIV-1 Qual Assay GXHIV-QA-CE-10 Cepheid AB Solna, Sweden 2016 HIV NAT Alere q HIV-1/2 Detect , , Alere GmbH Jena, Germany 100T/kit; 60T/kit; 30T/kit; 5T/kit; 20T/kit; 100T/kit; 100T/kit 10 cartridges/kit and instrument 10 cartridges/kit and instrument; 50 cartridges/kit and instrument
3 2016 HIV RDT DPP HIV 1/2 Assay Chembio Diagnostic Systems Inc. Medford, NY, USA 20T/kit 2016 HIV RDT OraQuick HIV 1/2 Rapid Antibody Test 5x4-0010, 5x x-0014 and 5x-0015 OraSure, Inc. Bethlehem, USA and Petchabun, Thailand 100T/kit; 500T/kit 2016 HBsAg EIA DS-EIA-HBsAg-0,01 В-1254, В-1252, В-1255, В-1256, В-231 RPC Diagnostics Systems Nizhniy Novgorod, Russia 192T/kit; ; 96T or 48T (if confirmation)/kit 200T/kit 2016 HIV Confirmatory Assay MP Diagnostics HIV Blot , MP Biomedicals Asia Pacific Pte.Ltd. Singapore, Singapore 18T/kit; 36T/kit 2016 HBsAg EIA Enzygnost HBsAg 6.0 and supplementary reagents kit for Enzygnost /TMB OPFM03, OPFM05, OPFM13(Q), OUVP17 Siemens Healthcare Diagnostics Products GmbH Marburg, Germany 960T/kit; 960T/kit (for higherthroughput) 2016 HIV EIA Enzygnost HIV Integral 4 and Supplementary reagents kit for Enzygnost /TMB OPKR03, OPKR05, OPKR07(Q), OUVP17 Siemens Healthcare Diagnostics Products GmbH Marburg, Germany 960T/kit; 960T/kit (for higherthroughput) 2016 HIV EIA AiD anti-hiv 1+2 ELISA WI-4396, WI Beijing Wantai Biological Pharmacy Enterprise Co. Beijing, China
4 2016 HIV RDT Rapid Test for Antibody to Human Immunodeficiency Virus (HIV) (Colloidal Gold Device) WJ-1810, WJ-1810E, WJ-1850, WJ-1850E Beijing Wantai Biological Pharmacy Enterprise Co. Beijing, China 10T/kit w/accessories; 10T/kit; 2015 CD4 Aquios CL flow cytometer B30166, B39101 B39102, B25697, B25698, B23536, B23538, B23533, B23534, B23535, B25700, B23502 Beckman Coulter Life Sciences Miami, FL, USA (instrument site) and Hialeah, FL, USA (reagent site) 2015 HIV/Syp RDT Alere HIV/Syphilis Duo 06FK30, 06FK35 Giheung-gu, Republic of Korea 25T/kit 2015 Malaria RDT SD BIOLINE Malaria Ag P.f/P.v 05FK80, 05FK81, 05FK82, 05FK83, 05FK86, 05FK87 Giheung-gu, Republic of Korea 25X1T/kit 2015 Malaria RDT SD BIOLINE Malaria Ag P.f (HRP2/pLDH) 05FK90, 05FKFK93, 05FK91, 05FK092 Giheung-gu, Republic of Korea 25X1T/kit 2015 HCV EIA INNO-LIA HCV Score Fujirebio Europe NV Zwijnaarde, Belgium 20T/kit 2015 HIV EIA DS-EIA-HIV-AGAB-SCREEN I-1654, I-1652, I-1656 RPC Diagnostics Systems Nizhniy Novgorod, Russia 96T/1 plate; 192T/2 plates; 480 T/5 plates 2015 HCV EIA Murex anti-hcv (version 4.0) 7F51-01, 7F51-02 DiaSorin South Africa (Pty) Ltd. Kyalami, South Africa 96T/kit
5 2015 Malaria RDT CareStart Malaria HRP2/pLDH (Pf/PAN) COMBO multi kit (product codes: RMRM , RMRM-02571CB, RMRM RB, RMRM-02571RI, RMRM-05071, RMRM-05071CB, RMRM-05071RB and RMRM- Access Bio, Inc. Somerset NJ, USA ; single kit (product codes: RMRU , RMRU-02571CB, RMRU RB, RMRU-02571RI, RMRU , RMRU-04071CB, RMRU RB and RMRU-04071RI) 40T/kit; multi kit (product codes: RMOM , RMOM-02571CB, RMOM RB, RMOM-02571RI, RMOM-05071, RMOM-05071CB, RMOM-05071RB and RMOM- ; 2015 Malaria RDT CareStart Malaria HRP2 (Pf) Access Bio, Inc. Somerset NJ, USA
6 single kit (product codes: RMOU , RMOU-02571CB, RMOU RB, RMOU-02571RI, RMOU-05071, RMOU-05071CB, RMOU-05071RB and RMOU- 40T/kit; multi kit (product codes: RMVM , RMVM-02571CB, RMVM RB, RMVM-02571RI, RMVM-05071, RMVM-05071CB, RMVM-05071RB and RMVM Malaria RDT CareStart Malaria HRP2/pLDH (Pf/Pv) COMBO Access Bio, Inc. Somerset NJ, USA single kit (product codes: RMVU , RMVU-02571CB, RMVU RB, RMVU-02571RI, RMVU-05071, RMVU-05071CB, RMVU-05071RB and RMVU- 40T/kit multi kit (product codes: RMPM , RMPM-02571CB, RMPM RB, RMPM-02571RI, RMPM-05071, RMPM-05071CB, RMPM-05071RB and RMPM-
7 2015 Malaria RDT CareStart Malaria HRP2/pLDH (Pf) Access Bio, Inc. Somerset NJ, USA single kit (product codes: RMPU , RMPU-02571CB, RMPU RB, RMPU-02571RI, RMPU , RMPU-05071CB, RMPU RB and RMPU- 40T/kit multi kit (product codes: RMNM , RMNM-02571CB, RMNM RB, RMNM-02571RI, RMNM-05071, RMNM-05071CB, RMNM-05071RB and RMNM Malaria RDT CareStart Malaria pldh (PAN) Access Bio, Inc. Somerset NJ, USA single kit (product codes: RMNU , RMNU-02571CB, RMNU RB, RMNU-02571RI, RMNU-05071, RMNU-05071CB, RMNU-05071RB and RMNU- 40T/kit 2015 HIV Confirmatory Assay INNO-Lia HIV I/II Score Fujirebio Europe NV Ghent, Belgium 20T/kit 2015 HCV EIA Bioelisa HCV , Biokit S.A. Barcelona, Spain
8 2015 HIV EIA Murex HIV Ag/Ab Combination 7G79-09 (GE41, 96 wells) and 7G79-11 (GE42, 480 wells) DiaSorin S.p.A UK Branch Dartford, UK 2015 HIV EIA Bioelisa HIV 1+2 Ag/Ab , Biokit S.A. Barcelona, Spain 2015 Malaria RDT First Response Malaria Ag P. falciparum (HRP2) Card Test I13FRC25, I13FRC30 Premier Medical Corporation Nani Daman and Sarigam, India 30T/kit 2014 COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test, version 2.0 (TaqMan 48) , , , , , , , Roche Molecular Systems, Inc. Branchburg, New Jersey, USA 48T/kit 2014 COBAS AmpliPrep/COBAS TaqMan HIV-1 Qualitative Test, version 2.0 (TaqMan 96) , , , , , , , Roche Diagnostics GmbH Mannheim, Germany 48T/kit 2014 HIV RDT SURE CHECK HIV 1/2 Assay HIV201 Chembio Diagnostic Systems Inc. Medford, NY, USA 25T/kit 2014 HBsAg EIA Murex HBsAg Version 3 with Murex HBsAg Confirmatory Version 3 9F80-01, 9F80-05, 2G27-01 DiaSorin S.p.A UK Branch Dartford, UK 2014 Malaria RDT ParaHIT f Ver. 1.0 Rapid Test for P.falciparum Malaria Device 55IC104-10, 55IC and, 55IC ARKRAY Healthcare Pvt. Ltd. Sachin (Surat), India 10T/kit;
9 2014 CD4 BD FACSPresto Near-Patient CD4 Counter with BD CD4%CD4/Hb Cartridge and BD FACSPresto Cartridges Kit , , Becton, Dickinson and Company, BD Biosciences San Jose, California, USA Singapore, Singapore : instrument : catridge (100/box) and : pipette (100/box) 2014 HIV RDT ABON HIV 1/2/O Tri-Line Human Immunodeficiency Virus Rapid Test Device IHI-T402WG, IHI-T0402WA ABON Biopharm (Hangzhou) Co. Ltd. Hangzhou, PR China 40T/kit 2013 HIV RDT VIKIA HIV 1/ biomérieux SA Marcy L Etoile, France 25T/kit 2013 HIV RDT INSTI HIV-1/HIV-2 Antibody Test , , , BioLytical Laboratories, Inc. Richmond, British Columbia, Canada 24T/kit; 24T/kit with support materials; 48T/kit; 48T/kit with support materials 2013 Malaria RDT SD BIOLINE Malaria Ag P.f/Pan SD BIOLINE Malaria Ag P.f/Pan (POCT) 05FK60, 05FK61, 05FK62, 05FK63, 05FK67 Giheung-gu, Republic of Korea 25x1T/kit; 1T/kit; 30T/kit 2013 Abbott RealTime HIV-1 Qualitative (Manual) 4N66-90, 4N66-80, 6K12-24, 9K15-01, 4N66-01, 4N66-66 (optional) Abbott Molecular Inc. Des Plaines, IL, USA 4x24T pack 2013 Abbott RealTime HIV-1 Qualitative (m 2000sp) 4N66-90, 9K14-02, 9K15-01, 4N66-80, 4N66-01, 6K12-24, 4N66-66 (optional) Abbott Molecular Inc. Des Plaines, IL, USA 4x24T pack
10 2013 HIV RDT SD BIOLINE HIV-1/ FK16, 03FK10 and 03FK17 Giheung-gu, Republic of Korea 30T/kit 2013 HIV EIA Genscreen ULTRA HIV Ag-Ab 72386, Bio-Rad Marnes La Coquette, France 2012 HIV RDT Uni-Gold HIV , N, E, N-100 Trinity Biotech Manufacturing Ltd. Bray, Ireland 20T/kit; 100T/kit 2012 CD4 Pima CD4 Test and ; and Alere GmbH Jena, Germany 25 cartridges/kit and instrument; 100 cartridges/kit and instrument 2012 CD4 BD FACSCount Instrument System with FACSCount Control Kit and BD FACSCount Reagent Kit (Absolute CD4+, CD8+, and CD3+ Counts) , , Becton, Dickinson and Company, BD Biosciences San Jose, CA, USA : instrument system : 25T /kit : 2012 CD4 BD FACSCount Instrument System with FACSCount Control Kit and BD FACSCount CD4 Reagent Kit (Absolute and Percentage CD4+ Counts) , , Becton, Dickinson and Company, BD Biosciences San Jose, CA, USA and Cayey, Puerto Rico : instrument system : 25T/kit : 2012 COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, version 2.0 (TaqMan 48) , , , or , and Optional: , Roche Diagnostics GmbH Mannheim, Germany : 48T/kit : 5.1 liters
11 2012 COBAS AmpliPrep/COBAS TaqMan HIV-1 Test, version 2.0 (TaqMan 96) , , , , or , Optional: , Roche Molecular Systems, Inc. Branchburg, NJ, USA : 48T/kit : 5.1 liters 2012 HIV RDT HIV 1/2 STAT-PAK HIV NucliSENS EasyQ HIV-1 v2.0 (Automated) ,280130, , ,280133, , ,200309, Chembio Diagnostic Systems Inc. Medford, NY, USA biomérieux SA Marcy L Etoile, France 20T/kit , , , and : 4x1L : 48 T/kit 2011 NucliSENS EasyQ HIV-1 v2.0 (Semi- Automated) , , , , and biomérieux SA Marcy L Etoile, France and : 48T/kit, : 48 T/kit 2011 HIV RDT Alere Determine HIV-1/2 7D2342, 7D2343, 7D2343SET Alere Medical Co. Ltd. Matsudo-shi, Chiba-ken, Japan 20T/kit; 100T/kit; 100T/kit 2011 HIV RDT HIV 1/2 STAT-PAK Dipstick HIV303 Chembio Diagnostic Systems Inc. Medford, NY, USA 1Tx30/kit 2011 Abbott RealTime HIV-1 (Manual) 2G31 (2G31-90, 2G31-80, 2G31-70), 2G31-66, 1L68-09, 9K15-01, 04J70-24, 04J71-93 Abbott Molecular Inc. Des Plaines, IL, USA 2G31-90: 96T/kit (4x24T); 2G31-80: 8 runs; 2G31-70: 4 calibration runs (1/6 months); 04J70-24: 96T/kit
12 2011 Abbott RealTim e HIV-1 (m 2000sp) 2G31 (2G31-90 or 2G31-010, 2G31-80, 2G31-70), 2G31-66, 1L68-09, 9K15-01, 04J70-24, 04J71-93, 9K14-02 Abbott Molecular Inc. Des Plaines, IL, USA 2G31-90: 96T/kit (4x24T) or 2G T/kit (4x24T); 2G31-80: 8 runs; 2G31-70: 4 calibration runs (1/6 months); 04J70-24: 96T/kit 2011 Abbott RealTim e HIV-1 (m 24sp) 3N06-01, 2G31(2G31-90, 2G31-80, 2G31-70), 2G31-66, 1L68-09, 9K15-01, 04J70-24, 04J71-93 Abbott Molecular Inc. Des Plaines, IL, USA 2G31-90: 96T/kit (4x24T); 2 G31-80: 8 runs; 2G31-70: 4 calibration runs (1/6 months); 04J70-24: 96T/kit 2010 Malaria RDT SD BIOLINE Malaria Ag P.f SD BIOLINE Malaria Ag P.f. (POCT) 05FK50, 05FK51, 05FK52, 05FK53 Giheung-ku, Republic of Korea 25T/kit, 25x1T/kit 1T/kit * Product originally prequalified in 2010 and amended in 2016 to include an additional product code. End of document
WHO list of prequalified in vitro diagnostic products
WHO list of prequalified in vitro diagnostic products : Rest of the world. Regulatory version applied to products not approved by stringent/mature NRAs or not regulated Last update: 17 March 2017 Year
WHO list of prequalified in vitro diagnostic products
WHO list of in vitro diagnostic products : Rest of the world. Regulatory version applied to products not approved by stringent/mature NRAs or not regulated Last update: 21 December 2016 Year 2016 HIV RDT
WHO list of prequalified in vitro diagnostic products
: Rest of the world. Regulatory version applied to products not approved by stringent/mature NRAs or not regulated 2018 CD4 Muse Auto CD4/CD4% kit MCA100101, MCA500101, MCA1XK101 EMD Millipore Corporation
WHO list of prequalified in vitro diagnostic products
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WHO list of prequalified in vitro diagnostic products
WHO list of in vitro diagnostic products : Rest of the world. Regulatory version applied to products not approved by stringent/mature NRAs or not regulated Last update: 8 April 2016 Year 2016 HIV RDT OraQuick
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